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DATE RECALL INITIATED:
May 8, 2001
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Antibody to Human Immunodeficiency Virus Type 1 p24 Antigen (HIVAG-1 Monoclonal )
72388M201 05/17/2001
75339M101 06/06/2001 (corrected)
MANUFACTURER:
Abbott Laboratories
Abbott Park, Illinois
REASON:
Limited testing at customers found that the lots exhibited an initial reactive rate of 1-4% for serum samples which is higher than the 0.42% initial reactivity rate documented in the package insert. The recall notification instructs establishments that have the recalled product in inventory to discontinue use and discard the product.
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.
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