PRODUCT CORRECTION: ABBOTT PRISM Reaction Trays

DATE CORRECTION INITIATED:

November 23, 2010

PRODUCT / LOT NUMBER:

Product:  ABBOTT PRISM Reaction Trays

Lot Number:
89898M500, 90044M500, 90359M500, 90579M500

List Number: 05A07-01

MANUFACTURER:

Abbott Laboratories
Abbott Park, Illinois

REASON:
Abbott has received customer complaints for an increase in the number of drain time (DT) error codes when using ABBOTT PRISM HBsAg (List Number 06D19) and ABBOTT PRISM HIV O Plus (List Number 03L68) assays and the ABBOTT PRISM Reaction Tray lots listed above. Customers are asked to discontinue use of these Reaction Tray lots with ABBOTT PRISM HBsAg and/or ABBOTT PRISM HIV O Plus and to contact ABBOTT for an alternate lot of ABBOTT PRISM Reaction Trays.

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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.