ARCHITECT HAVAB-M Reagent recallZ-1596-2010 · Abbott Diagnostics International, Ltd. · initiated Dec 30, 2009
Terminated All recalls posted in May 2010
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 Diagnostics International, Ltd. 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
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 category: Pending
What the company is doing
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.
Recall details
- Recall number
- Z-1596-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 30, 2009
- Posted by the FDA
- May 19, 2010
- Recalling firm
- Abbott Diagnostics International, Ltd.
- Quantity
- 1,326
- Product code
- LOL
- FDA submissions
- K063329
- Distribution
- Nationwide Distribution -- Including Puerto Rico.
Product description
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.
Code information (models, lots, serial numbers)
Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10.
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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