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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics

DATE RECALL INITIATED:

 

January 8, 2005

 

PRODUCT / LOT NUMBER / EXPIRATION DATE:

 

FETALSCREEN (Product Code 780540)

 

FS451 12/21/2004
FS452 1/18/2005
FS453 2/15/2005

MANUFACTURER:

 

Ortho-Clinical Diagnostics
Raritan, NJ

 

REASON:

Ortho-Clinical Diagnostics, Inc. (OCD) has received reports of weak or negative reactivity with the positive control provided in these kits. Testing has indicated that in the presence of a weakly reactive positive control, patient samples of the same concentration may not show rosetting. This could result in the laboratory not performing subsequent quantitative testing that may be required to determine the extent of fetal maternal hemorrhage. Consignees have been asked to discontinue using and discard any remaining kits.

 

 

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