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.
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