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Vaccines, Blood & Biologics

Correction of AUSZYME Monoclonal Assay-Abbott Laboratories


June 12, 2008


AUSZYME Monoclonal - List Number 1980

Lot Numbers: 64421M100, 64421M102, 64422M100, 64422M102, 64423M100, 64425M100, 64425M101


Abbott Laboratories
Abbott Park, IL


Recent product stability data indicate that lots 64425M100 and 64425M101 are not meeting Abbott's internal low-level HBs antigen sensitivity requirement. Use of Procedure A, C or D may produce false negative results with lots 64425M100 and 64425M101. Abbott has determined that the remaining lots listed share similar components and therefore have the potential for reduced sensitivity using Procedure A, C and D incubation methods. Customers are asked to discontinue using Procedures A, C or D when processing the AUSZYME Monoclonal assay with the lot numbers listed above and all future lots.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
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