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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM AUSAB Reagent Pack

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 Class 2 Recall
AxSYM AUSAB Reagent Pack
see related information
Date Posted January 24, 2008
Recall Status1 Terminated on May 09, 2008
Recall Number Z-0127-2008
Recall Event ID 45395
Premarket Approval
PMA Number
P060003/S003
Product Classification Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
Product Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064
Code Information Lot Numbers: 49535M100 and 55451M200
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall
Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action Abbott sent a Product Recall letter, dated 10/01/07, to all AxSYM AUSAB customers that received the affected lots of product, informing them of the manufacturing error that resulted in both false reactive and false nonreactive specimens. The letter provided the assay bias for both lots. The accounts were requested to examine their inventory for the affected lots; destroy any packs found; record the number of packs destroyed on the Customer Reply Form; and fax the completed form back to Abbott at 1-800-777-0051 prior to 10/12/07. They were also requested to evaluate patient results generated with these lots in alignment with the information provided in the letter to determine if additional action is necessary. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the lots; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT.
Quantity in Commerce 1,722 packs
Distribution Nationwide Distribution, including Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LOM and Applicant = ABBOTT LABORATORIES INC
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