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American National Red Cross/Biomedical Services, Washington, D.C., September 7, 2006, Adverse Determination Letter and Related Nov. 15th, 2006 Consent Decree Correspondence
ADVERSE DETERMINATION LETTER
Note: Although this is an accurate representation of the original Letter issued to the firm, it is not an exact copy. Slight modifications to the original Letter have been made to accommodate its conversion to the HTML format. A scanned copy of the original letter is available in PDF format at the bottom of this page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
September 7, 2006
ADVERSE DETERMINATION LETTER
BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. John F. McGuire
Executive Vice President
Biomedical Services
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
RE: United States v. American National Red Cross, Civil Action No. 903-0949 (JGP)
Dear Mr. McGuire:
Paragraph X of the Amended Consent Decree of Permanent Injunction (Decree) entered on April 15, 2003 permits the Food and Drug Administration (FDA) to assess a penalty for “each unit of unsuitable blood or blood component that [the American Red Cross (ARC)] distributes after entry of [the Decree] for which FDA determines that the release was preventable by ARC….” Paragraph X.A.2. of the Decree provides that “[i]f FDA determines that use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, FDA may assess a penalty of up to $5,000 for each such unit of blood or each such blood component. Notwithstanding the foregoing, FDA shall not assess ARC under this subparagraph (X.A.2) for the improper release of more than 100 units in any one event.”
FDA has recently completed a review of its database and files to identify classified1 recalls conducted by ARC. We identified 165 events in which ARC reported to FDA that it retrieved unsuitable blood components that were distributed during the period of April 15, 2003 through April 15, 2005 (this does not include any classified ARC-conducted recalls previously identified in the May 15, 2005 adverse determination letter). FDA determined that these events were preventable by ARC, that they meet the health hazard criteria of paragraph X.A.2. of the Decree, and that no penalty exception listed in Paragraph X.B. of the Decree applies. These events involved 12,233 unsuitable blood components.
Seven of the events involved more than 100 unsuitable blood components but were limited for penalty purposes to 100 units as provided by Paragraph X.A.2. of the Decree. The total number of unsuitable blood components for which FDA assessed a penalty under Paragraph X.A.2. of the Decree is 1083.
The unsuitable blood components are listed by event in the attachment to this letter. The events are identified by ARC-assigned biological product deviation numbers and FDA-assigned recall numbers and are arranged by ARC regions. The attached list does not include all events that occurred during the specified time period; it includes only those events classified by FDA as of May 1, 2006. After FDA review, additional penalties may be assessed for events that occurred during the aforementioned time period but are not listed in the attachment.
Paragraph X.A.2. of the Decree sets forth three factors FDA must consider when determining whether to assess a penalty and the amount of a penalty: “(1) the potential effect of the event on the public health, e.g., the number and seriousness of exposures; (2) ARC’s trends with respect to the same or similar events involving the release of unsuitable products; and (3) the degree to which ARC contributed to the improper release of the blood or blood components.” FDA has considered these factors and has assessed penalties accordingly for each unsuitable blood component (see attached list). The total penalty is $4,224,000.
As provided in the Decree, if ARC agrees with this adverse determination, it must, within 20 days of receipt of this letter, notify FDA of its intent to come into compliance with the Decree, submit a plan to do so, and pay the penalty no later than thirty days (30) thereafter. If ARC disagrees with FDA’s adverse determination, it shall respond in writing within 20 days of receipt of this letter, explaining the reason(s) for disagreeing with FDA’s determination. The response must be submitted to me at the Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, with a copy to Jesse Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N, Rockville, Maryland 20852.
Sincerely yours,
[Handwritten Signature]
Evelyn Bonnin
Director, Baltimore District
ATTACHMENT
cc: Mr. John F. McGuire
Interim President and CEO
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
C. William Cherry
Senior Vice President for Quality
and Regulatory Affairs
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
Mary Elcano
General Counsel
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
Bonnie McElveen-Hunter
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
[1] Recall classifications are numerical designations assigned by FDA to indicate the relative degree of health hazard presented by the recalled product. 21 C.F.R. § 7.3(m).
AMERICAN RED CROSS
CLASS II RECALLS FOR THE PERIOD 4/15/03 THROUGH 4/15/05 (EXCLUDING THOSE
PREVIOUSLY ADDRESSED IN THE MAY 15, 2005 PARAGRAPH X ADVERSE DETERMINATION LETTER)
The following regions have no recall information included in this report:
Alabama Region, FDA Registration 1073001
Central Plans, Wichita, KS, FDA Registration 1973042
Gulf Coast, Mobile, AL, FDA Registration 1073005
Midwest, Omaha, NE, FDA Registration 1973037
Northern California, Oakland, CA, FDA Registration 2971430
Puerto Rico, Rio Piedras, PR, FDA Registration 2675945
Tennessee Valley, Nashville, TN, FDA Registration 1073006
| Region/CFN | Biological Product Deviation Number/ Recall Number | Number of Recalled Products/Product Type | Reason for Recall | Penalty Amount Per Blood Component | Total Penalty Amount |
|---|---|---|---|---|---|
| Appalachian 1173010 | 2004-035-0621471 B-2423-5 | 1 – Red Blood Cells | Failure to control suspect blood component(s) (inappropriate release-enzyme immunoassay (EIA) positive hepatitis B core) | $5,000 | $5,000 |
| Arizona 2072997 | 2004-007-0416380 B-1480-5 | 1 - Red Blood Cells Leukocytes Reduced Irradiated | Component preparation (discrepant irradiation times documented) | $3,000 | $3,000 |
| 2004-007-0575401 B-0390-5 | 6 –Platelets Pheresis Leukocytes Reduced | Component preparation (no confirmation of leukocyte reduction) | $4,000 | $24,000 | |
| 2004-007-0649384 B-1763-5B-1764-5 | 1 - Platelets Pheresis Leukocytes Reduced Irradiated 1 – Fresh Frozen Plasma Pheresis | Donor eligibility (Blood Donation Record (BDR) question unanswered) | $3,000 | $6,000 | |
| Badger-Hawkeye 2173028 | 2003-03-20217889 B-1676-4 B-1677-4 B-1678-4 | 1 - Red Blood Cells Leukocytes Reduced 1 - Platelets Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to defer donor for increased risk of infection with hepatitis) | $4,000 | $12,000 |
| Carolinas Region 1073007 | 2004-012-0715488 B-0999-5 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 |
| 2004-012-0505489 B-1019-5 B-1020-5 | 3 - Red Blood Cells Leukocytes Reduced 1 – Plasma Frozen | Donor eligibility (failure to follow standard operating procedures (SOPs) for donors unable to answer health questions on their own) | $2,000 | $8,000 | |
| 2003-012-0122163 B-2381-5 | 1 - Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2003-012-0176772 B-1201-5 | 1 - Red Blood Cells Leukocytes Reduced | Testing (sample tube mislabeling mix-up) | $5,000 | $5,000 | |
| 2003-012-0210391 B-0078-6 | 3 - Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $12,000 | |
| 2004-012-0343049 B-1953-5 | 1 - Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (unit not placed on hold when deviation on BDR was found) | $5,000 | $5,000 | |
| 2004-012-0370556 B-0715-6 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2004-012-0378599 B-2382-5 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2004-012-0379026 B-2380-5 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2004-012-0398025 B-0931-6 B-0932-6 | 1 - Red Blood Cells Leukocytes Reduced 1 – Recovered Plasma | Failure to control suspect blood component(s) (inappropriate release of products from a deferred donor) | $5,000 | $10,000 | |
| 2004-012-0456922 B-0888-6 | 1 – Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (products were not discarded after discovery of an error on the BDR) | $5,000 | $5,000 | |
| 2004-012-04868895 B-0887-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in a malarial risk area) | $4,000 | $4,000 | |
| 2004-012-0544145 B-0716-6 | 2 – Red Blood Cells Pheresis Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $8,000 | |
| 2004-012-0559097 B-0860-6 | 1 – Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (intended for validation study) | $5,000 | $5,000 | |
| 2004-012-0577082 B-0885-6 B-0886-6 | 1 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (BDR question related to Creutzfeldt Jakob Disease (CJD) was unanswered) | $4,000 | $8,000 | |
| 2004-012-0589867 B-2384-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in a malarial risk area) | $4,000 | $4,000 | |
| 2004-012-0603330 B-0175-6 | 1 – Platelets Pheresis Leukocytes Reduced | Component preparation (platelet yield too high for storage in a single bag) | $4,000 | $4,000 | |
| 2004-012-0631857 B-0738-6 | 1 – Platelets Pheresis Leukocytes Reduced | Collection (failure to follow manufacturer’s instructions) | $3,000 | $3,000 | |
| 2004-012-0719187 B-0994-5 | 1 – Platelets Pheresis Leukocytes Reduced | Failure to control suspect blood component(s) (inappropriate release after noting discrepant information on the apheresis procedure record) | $5,000 | $5,000 | |
| 2005-012-0810629 B-2026-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2005-012-0821156 B-1928-5 | 1 - Platelets Pheresis Leukocytes Reduced | Collection (failure to follow manufacturer’s instructions) | $3,000 | $3,000 | |
| 2005-012-0882462 B-0415-6 | 17 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $68,000 | |
| 2005-012-0931808 B-0452-6 B-0453-6 | 1 – Red Blood Cells Leukocytes Reduced 3 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $16,000 | |
| 2004-012-0358460 B-0867-6 B-0868-6B-0869-6 B-0870-6B-0871-6 B-0872-6 B-0873-6 | 7 - Red Blood Cells Leukocytes Reduced 4 – Red Blood Cells Pheresis Leukocytes Reduced 6 – Platelets Pheresis Leukocytes Reduced 4 – Platelets Pheresis Leukocytes Reduced Irradiated 2 – Plasma Frozen Cryoprecipitate Reduced 2 – Cryoprecipitate AHF 4 – Recovered Plasma | Failure to control suspect blood component(s) (units not placed on hold when deviation on BDRs were found) | $5,000 | $145,000 | |
| Central Ohio 1573013 | 2004-016-0431548 B-2005-4 | 1 - Platelets Pheresis Leukocytes Reduced Irradiated | Failure to control suspect blood component(s) (inappropriate release after discovery of low platelet yield) | $5,000 | $5,000 |
| 2004-016-0449876 B-2012-4 | 2 – Red Blood Cells Leukocytes Reduced | Donor eligibility (quality control (QC)for Hemastat could not be verified) | $3,000 | $6,000 | |
| Connecticut 1273014 | B-0116-5 | 2 – Red Blood Cells Pheresis – Split Unit | Component preparation (failure to perform quality control testing) | $3,000 | $6,000 |
| B-0541-5 | 1 – Red Blood Cells Pheresis | Failure to control suspect blood component(s) (low volume Red Blood Cells) | $5,000 | $5,000 | |
| B-1237-5 B-1238-5 B-1239-5 B-1240-5 | 2 – Red Blood Cells Leukocytes Reduced 2 – Platelets Leukocytes Reduced 2 – Fresh Frozen Plasma 2 – Recovered Plasma | Donor eligibility (travel in a CJD risk area) | $4,000 | $32,000 | |
| Great Lakes 1873033 | 2004-018-0386370 B-1672-4 | 1 – Platelets Pheresis Leukocytes Reduced | Failure to control suspect blood component(s) (product intended for validation study) | $5,000 | $5,000 |
| 2004-018-0474355 B-0067-5 B-0068-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Recovered Plasma | Failure to control suspect blood component(s) (sterility may have been compromised) | $5,000 | $10,000 | |
| 2004-018-0503561 B-0072-5 B-0073-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to follow up on medications taken by donor) | $2,000 | $4,000 | |
| 2004-018-0631286 B-0549-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (hematocrit result was not documented) | $3,000 | $3,000 | |
| 2004-018-0687247 B-0595-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (hemoglobin was unsatisfactory and hematocrit not documented) | $3,000 | $3,000 | |
| 2005-018-0751704 B-1112-5 B-1113-5 | 2 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to follow SOPs for travel outside the U.S.) | $4,000 | $12,000 | |
| 2005-018-1081407 B-0587-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2005-018-1008818 B-0602-6 | 2 – Red Blood Cells Pheresis | Collection (sterility may have been compromised and failure to follow manufacturer’s instructions) | $5,000 | $10,000 | |
| Greater Alleghenies 2573016 | B-0208-5 | 1 – Platelets Pheresis Leukocytes Reduced | Component preparation (failure to determine white blood cell count and failure to follow manufacturer’s instructions) | $4,000 | $4,000 |
| B-0209-5 | 2 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (failure to defer donor for taking Feldene) | $2,000 | $4,000 | |
| B-0904-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| B-0924-5 | 1 – Red Blood Cells Pheresis Leukocytes Reduced | Failure to control suspect blood component(s) (unit not tagged for hematocrit testing after device malfunction) | $5,000 | $5,000 | |
| B-1337-5 B-1338-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Cryoprecipitated AHF | Donor eligibility (failure to defer donor for taking Avodart) | $5,000 | $10,000 | |
| B-1396-5 | 1 – Platelets Pheresis Leukocytes Reduced | Component preparation (platelet yield too high for single bag) | $4,000 | $4,000 | |
| B-1890-5 B-1891-5 B-1892-5 | 2 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma 2 – Recovered Plasma | Donor eligibility (failure to defer donor for CJD risk) | $4,000 | $20,000 | |
| B-1944-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to defer donor who reported taking medication on the Medication Deferral List) | $5,000 | $5,000 | |
| B-0320-6B-0313-6B-0317-6 B-0311-6 B-0314-6 B-0315-6 B-0318-6 B-0312-6B-0316-6 B-0319-6 B-0321-6 | 1 – Red Blood Cells CPDA-1 for Manufacturing Non-Injectables 2 – Red Blood Cells Pheresis Leukocytes Reduced 3 – Liquid Plasma 2,121 – Red Blood Cells Leukocytes Reduced 278 – Platelets Leukocytes Reduced 1 – Platelet Pheresis Leukocytes Reduced 176 – Cryoprecipiated AHF 36 – Red Blood Cells Leukocytes Reduced Irradiated 332 – Fresh Frozen Plasma 44 – Plasma Cryoprecipitated AHF 1755 – Recovered Plasma | Donor eligibility (use of obsolete CJD information form ) | $4,000 for each of 100 blood components | $400,000 | |
| Greater Chesapeake and Potomac 1173011 | 2004-053-0420855 B-0480-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility ( BDR question pertaining to Avodart unanswered) | $5,000 | $5,000 |
| 2004-053-0571810 B-0763-5 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility ( failure to defer donor for taking Tazorac) | $2,000 | $2,000 | |
| 2004-053-0560252 B-0765-5 | 3 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $12,000 | |
| 2004-053-0517279 B-0766-5 | 2 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $8,000 | |
| 2004-053-0580808 B-0841-5 B-0842-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Recovered Plasma | Donor eligibility (failure to defer donor for history of hepatitis) | $4,000 | $8,000 | |
| 2004-053-0689598 B-1580-5 B-1581-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Failure to control suspect blood component(s) (quarantine error with overweight unit) | $5,000 | $10,000 | |
| Greater Ozarks-Arkansas 2372998 | 2004-055-0413840 B-2020-5 B-2021-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to defer donor for hepatitis risk) | $4,000 | $8,000 |
| 2003-055-0219886 B-2073-5 | 4 – Fresh Frozen Plasma | Failure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells) | $5,000 | $20,000 | |
| 2003-055-0280152 B-2121-5 | 156 – Platelets Pheresis Leukocytes Reduced | Component preparation (failure to perform monthly QC for platelet pheresis products) | $3,000 for each 100 blood components | $300,000 | |
| 2003-055-0136101 B-2202-5 | 1 – Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (inappropriate release after reactive West Nile pool was reported) | $5,000 | $5,000 | |
| 2005-055-0953356 B-0689-6 B-0691-6 B-0692-6 | 5 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma 3 – Recovered Plasma | Donor eligibility (failure to defer donor for hepatitis risk) | $4,000 | $36,000 | |
| Heart of America 1473043 | 2004-040-0643167 B-0465-5 | 1 – Platelets Pheresis Leukocytes Reduced | Failure to control suspect blood component(s) (sterility may have been compromised) | $5,000 | $5,000 |
| 2004-040-0642930 B-0466-5 | 3 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $12,000 | |
| 2004-040-0642994 B-0467-5 | 3 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $12,000 | |
| 2005-040-0804626 B-1327-5 B-1328-5 | 1 – Platelets Pheresis Leukocytes Reduced 1 – Platelets Pheresis Leukocytes Reduced Irradiated | Collection (failure to follow manufacturer’s instructions) | $3,000 | $6,000 | |
| 2005-040-0886454 B-1679-5 | 3 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to document the hematocrit reading) | $3,000 | $9,000 | |
| 2005-040-1175515 B-0728-6 | 1 – Red Blood Cells | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| Indiana-Ohio 1873031 | 2005-038-0799491 B-1104-5 | 1 – Red Blood Cells | Failure to control suspect blood component(s) (inappropriate release after receiving post donation information) | $5,000 | $5,000 |
| 2004-038-0348688 B-1114-5 B-1115-5 B-1116-5 B-1118-5 B-1119-5 B-1120-5 | 4 – Red Blood Cells 189 - Red Blood Cell, Leukocytes Reduced 18 – Platelets 1 – Platelets Irradiated 30 - Fresh Frozen Plasma 141 - Recovered Plasma | Donor eligibility (use of obsolete SOP for CJD risk) | $4,000 for each of 100 blood components | $400,000 | |
| 2005-038-0867114 B-1815-5 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| Lewis and Clark 3072990 | 2003-020-0079860 B-0721-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (BDR question unanswered) | $3,000 | $3,000 |
| 2003-020-0221986 B-0211-6 B-0212-6 B-0213-6 | 2 – Fresh Frozen Plasma 1 – Plasma Cryoprecipitated Reduced 1 – Cryoprecipitated AHF | Failure to control suspect blood component(s) (inappropriate release after discovery of clots in red blood cells) | $5,000 | $20,000 | |
| 2003-020-0279664 B-0630-6 B-0631-6 | 34 – Platelets Pheresis Leukocytes Reduced 5 – Platelets Pheresis Leukocytes Reduced Irradiated | Component preparation (failure to perform QC testing) | $3,000 | $117,000 | |
| Mid-Atlantic 1173024 | 2004-029-0594370 B-0445-5 | 1 – Platelets Pheresis Leukocytes Reduced Irradiated | Component preparation (volume too great for one collection bag) | $4,000 | $4,000 |
| 2004-029-0606242 B-0461-5 B-0462-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Frozen Plasma | Donor eligibility (failure to defer donor for CJD risk) | $4,000 | $8,000 | |
| 2004-029-0700521 B-1538-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| Missouri-Illinois 1973035 | 2005-011-0797069 B-0638-6 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (donor incorrectly removed from the National Donor Deferral Registry) | $5,000 | $5,000 |
| 2005-011-0793209 B-0684-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| New England 1270026 | B-1888-4 | 1 – Platelets Pheresis Leukocytes Reduced | Collection (failure to follow manufacturer’s instructions) | $3,000 | $3,000 |
| B-0501-5 | 1 – Red Blood Cells | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| B-0502-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| B-0670-5 | 1 – Platelets Pheresis Leukocytes Reduced Irradiated | Collection (sterility may have been compromised and failure to follow manufacturer’s instruction) | $5,000 | $5,000 | |
| B-0723-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| B-0947-5 | 2 - Platelets Pheresis Leukocytes Reduced | Collection (sterility may have been compromised and failure to follow manufacturer’s instructions) | $5,000 | $10,000 | |
| B-0951-5 | 1 - Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| B-0956-5 | 1 – Red Blood Cells | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| B-1006-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| B-1007-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| B-1009-5 | 1 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (failure to defer donor for taking Proscar) | $5,000 | $5,000 | |
| B-1023-5 | 1 – Fresh Frozen Plasma | Failure to control suspect blood component(s) (inappropriate release after discovery of clots in red blood cells) | $5,000 | $5,000 | |
| B-1996-5 B-1997-5 | 2 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to defer donor for taking Proscar) | $5,000 | $15,000 | |
| B-2005-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| B-0625-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malaria risk area) | $4,000 | $4,000 | |
| New York-Penn 2438445 | 2004-001-0532479 B-2253-5 B-2254-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Recovered Plasma | Donor eligibility (failure to defer donor for hepatitis risk) | $4,000 | $8,000 |
| North Central 2173038 | 2003-017-0112629 B-0424-6 | 1 – Platelets Leukocytes Reduced | Donor eligibility (failure to defer donor for HIV risk) | $5,000 | $5,000 |
| 2003-017-0114568 B-0503-6 | 1 – Platelets Leukocytes Reduced | Component preparation (sterility may have been compromised) | $5,000 | $5,000 | |
| 2004-017-0320991 B-1097-6 | 1 – Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (overweight unit) | $5,000 | $5,000 | |
| 2004-017-0464920 B-1113-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2004-017-0466796 B-1131-6 | 2 – Red Blood Cells Leukocytes Reduced | Component preparation (failure to assure leukoreduction) | $4,000 | $8,000 | |
| Northeastern Pennsylvania 2573018 | B-0069-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (hemoglobin not documented) | $3,000 | $3,000 |
| B-0671-5 | 1 – Whole Blood | Donor eligibility (failure to defer donor for urinary tract infection) | $4,000 | $4,000 | |
| B-0656-5 | 2 – Red Blood Cells Leukocytes Reduced | Collections (error on daily quality control record) | $3,000 | $6,000 | |
| B-1853-5 | 1 – Red Blood Cells | Failure to control suspect blood component(s) (OC was not properly performed on the hematocrit centrifuge) | $5,000 | $5,000 | |
| B-1852-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to have a hematocrit value on the BDR) | $3,000 | $3,000 | |
| B-2375-5 B-2376-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Cryoprecipitate AHF | Donor eligibility (failure to defer donor with melanoma) | $4,000 | $8,000 | |
| B-0233-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| Northern Ohio 1573019 | 2004-042-0686603 B-2141-5 B-2142-5 B-2143-5B-2144-5B-2145-5 B-2146-5 B-2147-5 | 6 – Red Blood Cells 719 – Red Blood Cells Leukocytes Reduced 1 – Red Blood Cells Leukocytes Reduced Washed 50 – Red Blood Cells Apheresis Leukocytes Reduced 249 – Platelets Leukocytes Reduced 107 – Fresh Frozen Plasma 15 – Plasma | Donor eligibility (inadequate donor screening) | $5,000 for each of 100 blood components | $500,000 |
| 2005-042-0931991 B-0158-6 | 1 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| Pacific Northwest 3072996 | 2003-021-0223957 B-0492-5 | 1 – Red Blood Cells Leukocytes Reduced | Collection (sterility may have been compromised and failure to follow manufacturer’s instructions) | $5,000 | $5,000 |
| 2004-021-0292966 B-1407-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2004-021-0308462 B-1426-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2004-021-0346465 B-0479-6 B-0480-6 | 1 – Red Blood Cells Leukocytes Reduced 5 – Platelets Pheresis Leukocytes Reduced | Donor eligibility (travel to malaria risk area) | $4,000 | $24,000 | |
| Penn-Jersey 2573021 | B-2037-4 | 1 – Red Blood Cells Pheresis | Component preparation (sterility may have been compromised and failure to follow manufacturer’s instructions) | $5,000 | $5,000 |
| B-2051-4 | 1 – Red Blood Cells Pheresis | Component preparation (sterility may have been compromised and failure to follow manufacturer’s instructions) | $5,000 | $5,000 | |
| B-0819-5 | 5 – Red Blood Cells Leukocytes Reduced | Collections (daily QC of Hematastat was unacceptable) | $3,000 | $15,000 | |
| B-0834-5B-0835-5 | 5 – Red Blood Cells Leukocytes Reduced Irradiated 6 – Platelets Pheresis Leukocytes Reduced Irradiated | Component preparation (discrepant irradiation times documented) | $3,000 | $33,000 | |
| B-1434-5 B-1435-5 | 221 – Platelets Pheresis Leukocytes Reduced 27 – Platelet Pheresis Leukocytes Reduced Irradiated | Component preparation (monthly QC of pheresis products not performed) | $3,000 for each of 100 blood components | $300,000 | |
| B-1531-5 B-1532-5B-1533-5 | 1976 – Platelets Pheresis Leukocytes Reduced 736 – Platelets Pheresis Leukocytes Reduced Irradiated 1635 – Fresh Frozen Plasma | Component preparation (manufacturer’s instructions were updated but written procedures had not been updated) | $4,000 for each of 100 blood components | $400,000 | |
| B-1542-5 B-1543-5 | 1 – Red Blood Cells Leukocyte Reduced 1 – Fresh Frozen Plasma | Failure to control suspect blood component(s) (failure to quarantine components after receiving post donation information) | $5,000 | $10,000 | |
| B-1749-5 | 1 – Red Blood Cells | Failure to control suspect blood component(s) (overweight units) | $5,000 | $5,000 | |
| B-1881-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| B-1882-5 | 1 – Platelets Leukocytes Reduced | Donor eligibility (failure to defer donor for HIV risk) | $5,000 | $5,000 | |
| B-1906-5 | 13 – Platelets Pheresis Leukocytes Reduced | Storage/Shipping (shipment of products exceeded time allowed for shipping) | $4,000 | $52,000 | |
| River Valley 1073003 | 2004-024-0324987 B-1759-5 B-1760-5 | 730 – Platelets Leukocytes Reduced 90 – Platelets Leukocytes Reduced Irradiated | Component preparation (low platelet yields) | $4,000 for each of 100 blood components | $400,000 |
| South Carolina 1073009 | 2003-036-0157079 B-0965-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to defer donor for taking Lupron) | $2,000 | $2,000 |
| 2005-036-0859145 B-1009-6 | 5 – Platelets Pheresis Leukocytes Reduced | Storage/Shipping (time in transit not documented) | $2,000 | $10,000 | |
| 2005-036-0978405 B-0921-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to defer donor for lymphoma) | $4,000 | $4,000 | |
| Southeastern Michigan 1873044 | 2004-013-0403966 B-1424-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 |
| 2004-013-0652182 B-1425-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2004-013-0514574 B-1454-5 B-1455-5 B-1456-5 | 1 - Red Blood Cells Leukocytes Reduced 1 – Platelets Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to defer donor for human T lymphotropic virus (HTLV) risk) | $4,000 | $12,000 | |
| 2004-013-0588706 B-1483-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2005-013-0813171 B-2292-5 B-2293-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Fresh Frozen Plasma | Donor eligibility (failure to deter donor for taking Avodart) | $5,000 | $10,000 | |
| 2005-013-0979194 B-0015-6 | 1 – Platelets Pheresis Leukocytes Reduced Irradiated | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2005-013-0948006 B-0038-6 B-0039-6 | 1 – Red Blood Cells Leukocytes Reduced 1 – Platelets Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $8,000 | |
| 2004-013-0414712 B-0124-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to defer donor for HTLV risk) | $4,000 | $4,000 | |
| Southern 1073000 | 2003-003-0268123 B-0445-6 | 3 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $12,000 |
| 2003-003-0137009 B-0447-6 | 10 – Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (overweight unit) | $5,000 | $50,000 | |
| 2003-003-0171218 B-0519-6 | 1 Red Blood Cells Leukocytes Reduced | Donor eligibility (travel in malarial risk area) | $4,000 | $4,000 | |
| 2004-003-0655027 B-0736-6 | 1 – Platelets Pheresis Leukocytes Reduced | Component preparation (inappropriate release of unit with unacceptable platelet yield) | $4,000 | $4,000 | |
| 2004-003-0362554 B-0737-6 | 1 – Platelets Pheresis | Component preparation (inappropriate release of unit with unacceptable platelet yield) | $4,000 | $4,000 | |
| 2004-003-0508176 B-0762-6 | 1 – Platelets Pheresis Leukocytes Reduced | Component preparation (inappropriate release of unit with unacceptable platelet yield) | $4,000 | $4,000 | |
| 2004-003-0366103 B-0807-6 | 1 – Platelets Pheresis | Failure to control suspect blood component(s) (BDR questions related to HIV risk were unanswered) | $5,000 | $5,000 | |
| 2004-003-0591717 B-0895-6 | 3 – Plasma Frozen | Failure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells) | $5,000 | $15,000 | |
| 2004-003-0424198 B-0896-6 | 1 – Platelets Pheresis Leukocytes Reduced | Component preparation (inappropriate release of unit with unacceptable platelet yield) | $4,000 | $4,000 | |
| 2004-003-0577474 B-0947-6 | 2 – Platelets Pheresis Leukocytes Reduced | Failure to control suspect blood component(s) (product did not meet product specifications) | $5,000 | $10,000 | |
| 2004-003-0339931 B-1008-6 | 1 – Red Blood Cells Leukocytes Reduced | Failure to control suspect blood component(s) (BDR high risk question unanswered) | $5,000 | $5,000 | |
| Southern California 2072994 | 2003-006-0186567 B-0624-4 | 1 – Red Blood Cells Leukocytes Reduced | Storage/Shipping (product stored at incorrect temperature) | $4,000 | $4,000 |
| 2004-006-036788 B-1045-5 | 2 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $8,000 | |
| 2004-006-0360704 B-1049-5 B-1050-5 | 2 – Red Blood Cells 1 – Fred Frozen Plasma | Donor eligibility (failure to defer donor for body piercing) | $4,000 | $12,000 | |
| 2004-006-0325150 B-1768-5 B-1769-5 | 5 – Platelets Pheresis Leukocytes Reduced 1 – Platelets Pheresis Irradiated | Component preparation (failure to perform product QC testing) | $3,000 | $18,000 | |
| 2004-006-0321033 B-1910-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2003-006-0230785 B-0277-6 | 2 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $8,000 | |
| 2004-006-0375556 B-0672-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2003-006-0155824 B-0834-6 | 1 – Platelets Pheresis Irradiated | Failure to control suspect blood component(s) (inappropriate release-elevated platelet count) | $5,000 | $5,000 | |
| 2004-006-0501165 B-1176-6 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| Southwest 1673040 | 2003-0490152156 B-1652-5 B-1653-5 | 1 – Red Blood Cells Leukocytes Reduced 1 – Recovered Plasma | Donor eligibility (failure to defer donor for taking Proscar) | $5,000 | $10,000 |
| 2003-049-0226992 B-1680-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to defer donor for low Hct) | $3,000 | $3,000 | |
| 2004-049-0709793 B-1698-5 | 1 – Platelets Pheresis Leukocytes Reduced | Collection (sterility may have been compromised) | $5,000 | $5,000 | |
| 2003-049-0182598 B-1699-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (failure to defer donor for unacceptable hemoglobin level) | $3,000 | $3,000 | |
| 2004-049-0564594 B-1726-5 | 1 – Red Blood Cells Leukocytes Reduced | Donor eligibility (travel to malarial risk area) | $4,000 | $4,000 | |
| 2004-049-0620192 B-1739-5 | 2 – Platelets Pheresis Leukocytes Reduced | Failure to control suspect blood component(s) (product intended for validation study) | $5,000 | $10,000 | |
| 2005-049-0819904 B-0877-6 | 1 – Red Blood Cells | Donor Eligibility (BDR question pertaining to CJD was unanswered) | $4,000 | $4,000 | |
| Western Lake Erie 1573020 | 2004-050-0305012 B-0082-6 B-0083-6 B-0084-6 | 1 – Red Blood Cells Leukocytes Reduced 1 – Cryoprecipitated, AHF 1 – Recovered Plasma | Donor eligibility (failure to defer donor for CJD risk) | $4,000 | $12,000 |
| 2004-050-0654999 B-1000-6 B-1001-6 B-1002-6 | 1 – Red Blood Cells Leukocytes Reduced 1 – Cryoprecipitated AHF 1 – Recovered Plasma | Donor eligibility (failure to defer donor for hepatitis risk) | $4,000 | $12,000 |
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