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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.


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.