ARCHITECT HAVAB-M 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.
FDA Recall Z-1596-2010 · Posted 2010-05-19
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Recalling FirmAbbott Diagnostics International, Ltd.
Recall StatusTerminated
Product CodeLOL
Date Initiated2009-12-30
Date Terminated2011-08-31
Product Quantity1,326
Reason for Recall
There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.
Firm Action
Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.
Root Cause
Pending
Distribution Pattern
Nationwide Distribution -- Including Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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