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DATE RECALL INITIATED:
January 6, 2003
LOT NUMBERS / EXPIRATION DATES:
92527M101 4/15/2003
MANUFACTURER:
Abbott Laboratories
Abbott Park, Illinois
REASON:
The manufacturer found an increase in frequency of Negative Control Out of Range High values, which results in an increased likelihood of invalid assay runs. Previous assays performed with this lot, in which package insert requirements were met, are valid assays and results of such assays should be considered valid. Establishments that have the recalled product in inventory are instructed to discontinue use and destroy any remaining 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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