• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics

Recall Notification - 1/8/2005 - Product Code 780540, Lots FS451, FS452, and / or FS453

--------------------------------------------------------------------------------

Additional Considerations for Patient Management:

It is possible that this test did not identify some patients who experienced fetal-maternal hemorrhage (FMH) of greater than 30 mL whole blood (15 mL packed cells) as candidates for treatment with more than the usual post-partum Rh Immune Globulin (RhIG) dose of 300 µg. Literature indicates that the risk of FMH greater than 30 mL (15 mL packed cells) is in the magnitude of less than 0.3% 1, 2 in an unselected population at the time of delivery.

Blood Bank Medical Directors Should:

Identify all Rh negative patients who delivered an Rh positive baby and had a negative test result with FETALSCREEN Lots FS451, FS452, and/or FS453.

Attending Physicians Should:

Explain the situation to affected patients and consider discussing the following information and options with them
When FMH in excess of 30 mL whole blood has occurred, investigators have postulated that additional RhIG could be administered with some benefit for up to 28 days after the event. 1, 2 There is no known incremental risk of adverse drug effects associated with delayed administration of additional RhIG, but the actual benefit has not been tested or proven in prospective clinical studies.

When concern for Rh alloimmunization exists, patients can be screened subsequently for formation of anti-D antibodies (Type and Screen). This screening should be performed no earlier than 6 months after receiving a dose of RhIG, as the drug may cause the antibody screen to be positive and not accurately indicate the patient's immune status. If an anti-Rho(D) antibody is identified, measures consistent with normal clinical management of patients at risk of Rh Hemolytic Disease of the Fetus/Newborn (HDN) should be instituted.
Patients with a negative antibody test should be made aware of the fact that they could be sensitized despite this test result, and that antibodies, and related complications might nonetheless develop in a subsequent pregnancy involving an Rh positive fetus.
Please feel free to contact Ortho-Clinical Diagnostics Customer Technical Services (1-800-421-3311, Options 2,1,1) if you need further information or assistance.

References:

Bowman J. Thirty-Five years of Rh prophylaxis. Transfusion. 2003; 43:1661-1666.

Bowman JM. The prevention of Rh immunization. Transfusion Medicine Reviews 1988; Vol 2, No 3: 129-150.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002