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DATE RECALL INITIATED: February 17, 2003 LOT NUMBERS / EXPIRATION DATES: 92677M200   12/21/2002 92677M201   12/21/2002 92677M202   12/21/2002 95132M100   4/9/2003 95132M101   4/9/2003 MANUFACTURER: Abbott Laboratories Abbott Park, Illinois REASON: The manufacturer found an increase in the initial reactive rate when compared to historical performance expectations as shown in the package insert. This may result in an increased likelihood of invalid assay runs. Specificity, as defined by repeat reactive rate, and sensitivity continue to meet all performance requirements. 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.

Updated February 24, 2003

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