Z-2413-2011

ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative...

Name: Z-2413-2011 ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative...
Creator: Abbott Laboratories
Published: 2011-04-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-04-20 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM... on 2011-04-20. The reason FDA records is "The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2413-2011
Status: Terminated
Initiated: 2011-04-20
Posted: 2011-06-06
Terminated: 2012-02-10
Recalling firm: Abbott Medical
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
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
Reason for recall: The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: List 6L21-25, lot 93794HN00, expiration date 2011-09-15

Product code LOL

K063329Class IIAbbott Architect Havab-MAbbott Laboratories / cleared 2007-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)