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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT HAVABM Assay Reagent

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  Class 2 Device Recall ARCHITECT HAVABM Assay Reagent see related information
Date Initiated by Firm April 20, 2011
Date Posted June 06, 2011
Recall Status1 Terminated 3 on February 10, 2012
Recall Number Z-2413-2011
Recall Event ID 58591
510(K)Number K063329  
Product Classification Hepatitis a test (antibody and igm antibody) - Product Code LOL
Product ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25
Code Information List 6L21-25, lot 93794HN00, expiration date 2011-09-15
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall		 The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Abbott Laboratories issued a Product Recall letters dated April 20, 2011 to all affected customers that received ARCHITECT HAVAB-M reagent, lot 93794HN00. The letters informed the accounts of the increased grayzone and/or reactive results and were instructed to discontinue use of the lot and destroy any remaining inventory of the lot according to laboratory procedures. If the account did not have an alternate lot of reagent, they were told to continue using the recalled lot until their lab receives the replacement lot, and to perform supplemental testing with another HAVAB-M method to confirm the results for all specimens that are grayzone or reactive. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. For further questions regarding this please contact Abbott at 1-877-422-688
Quantity in Commerce 788 kits
Distribution Nationwide Distribution including Puerto Rico
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LOL and Original Applicant = ABBOTT LABORATORIES
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