Z-1596-2010

ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection...

Name: Z-1596-2010 ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection...
Creator: Abbott Diagnostics International, Ltd.
Published: 2009-12-30
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2009-12-30 / Terminated

FDA source

Abbott Diagnostics International, Ltd. began a recall of ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV)... on 2009-12-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1596-2010
Status: Terminated
Initiated: 2009-12-30
Posted: 2010-05-19
Terminated: 2011-08-31
Recalling firm: Abbott Diagnostic International, Ltd.
Product: 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.
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
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.
FDA root cause: Pending
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.
Quantity in commerce: 1,326
Distribution: Nationwide Distribution -- Including Puerto Rico.
Product codes and lots: Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10.

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)