ARCHITECT HAVAB-M Assay Reagent recallZ-2413-2011 · Abbott Laboratories · initiated Apr 20, 2011
Terminated All recalls posted in June 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-2413-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 20, 2011
- Posted by the FDA
- Jun 6, 2011
- Recalling firm
- Abbott Laboratories
- Quantity
- 788 kits
- Product code
- LOL
- FDA submissions
- K063329
- Distribution
- Nationwide Distribution including Puerto Rico
Product description
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 (models, lots, serial numbers)
List 6L21-25, lot 93794HN00, expiration date 2011-09-15
Other devices under the same FDA submission
1 device cleared under K063329 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARCHITECT 6L21-25Abbott GmbH · Hepatitis a test (antibody and igm antibody)3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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