Abbott Alinity m HBV AMP Kit Recall: Potential for High Negative Results
Abbott recalls Alinity m HBV AMP Kit (US and CE) due to potential misquantitation causing high results for negative samples. Affected lots listed in the recall notice.
Lower-risk recall
There is a potential for misquantitation high results for negative samples.
Contact the company
What happened, in plain English
Abbott is recalling the Alinity m HBV AMP Kit for possible high results in negative samples. This could lead to incorrect test outcomes, but the recall does not specify a risk of injury or serious harm. Read more at govinfonow.com/recall/60984-abbott-alinity-m-hbv-amp-kit-recall-potential-for-high.
Source Summary by GovInfoNow · govinfonow.com/recall/60984-abbott-alinity-m-hbv-amp-kit-recall-potential-for-high · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0884-2022
Cite this page
“Abbott Alinity m HBV AMP Kit Recall: Potential for High Negative Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60984-abbott-alinity-m-hbv-amp-kit-recall-potential-for-high. Based on FDA recall #Z-0884-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0884-2022%22&limit=1).
Why it’s dangerous
The kit may produce falsely high results for negative samples, meaning tests that should show no hepatitis B virus could indicate a positive result. This could lead to incorrect diagnoses or treatment decisions.
Who’s affected
Users of the Alinity m HBV AMP Kit in the US and Europe who purchased the specific lots listed in the recall notice are affected. Laboratory staff and healthcare providers using the kit are most at risk of incorrect test results.
How to tell if you have this one
Check the lot numbers on your Alinity m HBV AMP Kit packaging. US lots include 519756, 523799, 524361, 381583, 529391, 529687, 530273, 531598. CE lots include 519755, 520957, 522137, 523798, 524059, 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596.
- Brand
Abbott- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0883-2022 | Alinity m HBV Application Specification File (US and CE); List Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00 | — |
| Z-0884-2022 | Alinity m HBV AMP Kit (US and CE); List Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596 | 4966 kits, updated 101/17/2023 |
What to do — step by step
Check Kit Lot Numbers
Identify the lot numbers on your Alinity m HBV AMP Kit packaging to see if they match the affected lots listed in the recall.
Where it went and when
Where it was distributed
Distributed in 14 states, and outside the U.S.
FDA distribution: “US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Illinois, Indiana, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas, Virginia.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0884-2022 (March 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0884-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.