Correction
AUSZYME Monoclonal Assay
DATE NOTIFICATION INITIATED:
June 12, 2008
PRODUCT / LOT NUMBER:
AUSZYME Monoclonal - List Number 1980
Lot Numbers: 64421M100, 64421M102, 64422M100, 64422M102, 64423M100, 64425M100, 64425M101
MANUFACTURER:
Abbott Laboratories
Abbott Park, IL
REASON:
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.
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.