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DATE RECALL INITIATED:
September 5, 2002
LOT NUMBER / EXPIRATION DATE:
91988M101 1/22/2003
MANUFACTURER:
Abbott Laboratories
Abbott Park, IL
REASON:
Investigation at Abbott Laboratories identified that ABBOTT HCV EIA 2.0, lot number 91988M101, may contain vials of Conjugate Concentrate, lot number 84911M301, that were overfilled by approximately
0.8 mL. Not all vials were overfilled. The cause of the overfill has been determined to be a manufacturing error during filling of the Conjugate Concentrate.
Consignees have been asked to contact the manufacturer to arrange for product return.
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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