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Important Information Relating to Recall of Fetal Cell Screening Kit - 1/19/2005 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. 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.

Updated January 19, 2005

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