FDA Recall Terminated

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

Recall: Z-2413-2011 · Initiated April 20, 2011

Recall

Recall Number: Z-2413-2011
Event Number: 58591
Firm: Abbott Laboratories
FEI Number: 1415939
Product Code: LOL
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: April 20, 2011
Posted: June 6, 2011
Terminated: February 10, 2012
Address: 100 Abbott Park Rd, Abbott Park, IL, 60064-3502

Description

Reason

The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.

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

Distribution

Nationwide Distribution including Puerto Rico

Quantity

788 kits