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U.S. Department of Health and Human Services

Medical Devices

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Biosite Incorporated, Triage Cardiac Panel

Recall Class:
Class I
Date Recall
Initiated:
April 27, 2009
Product:

Triage Cardiac Panel, Catalog No. 97000HS, Lot #W44467B, shipped as 25 individually pouched devices per kit box. (This recall is limited only to this catalog and lot number).

This product was manufactured only on January 23, 2009 and distributed from January 24, 2009 through February 17, 2009.

Use:
This test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).
Recalling Firm:
Biosite Inc.
9975 Summers Ridge Road
San Diego, California 92121
Reason for Recall:
The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have.
Public Contact:
Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week).
FDA District:
Los Angeles
FDA Comments:

On April 27, 2009, the company sent an urgent recall notice with an attached “Customer/Distributor Verification Form” by FAX, email, or direct mail. Customers were:

  • Informed of the reason for the recall.
  • Instructed to immediately discontinue all use of the products.
  • Instructed to discard all affected products according to their regulations.
  • Given two options.
    • Option 1: To complete and FAX the enclosed Verification Form within 10 days to confirm receipt of the notice and to indicate the number of kits discarded from their inventory and number of product replacements to be sent to them.
    • Option 2: To contact Inverness Medical Technical Services at 1-877-441-7440 (select option 2 from the phone prompt). A company representative would confirm the number of kits discarded from the customer’s inventory and arrange for replacement products to be sent to them.
  • Provided with Biosite’s telephone, FAX, and email contact if there were any questions dealing with the recall notice.

For more information about this recall, please see the company’s press release.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.