Lower risk Medical device recall · FDA · Published October 30, 2023

Abbott Alinity m HCV AMP Kit Recall: False Positive Results Risk

Abbott recalls Alinity m HCV AMP kits with specific lot numbers due to increased false positives in hepatitis C testing. Affected kits may produce inaccurate results, requiring replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0407-2024Medical device Abbott ›

Lower-risk recall

Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.

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Contact the company

Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315

✎ GovInfoNow plain-language explainer

Abbott is recalling two specific models of Alinity m HCV AMP kits (lot numbers 08N50-095 and 08N50-090) because they can cause false positive results in hepatitis C tests. This means some patients might receive incorrect diagnoses, which could lead to unnecessary treatment or missed health issues. Read more at govinfonow.com/recall/56991-abbott-alinity-m-hcv-amp-kit-recall-false-positive-results.

Source Summary by GovInfoNow · govinfonow.com/recall/56991-abbott-alinity-m-hcv-amp-kit-recall-false-positive-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0407-2024

Cite this page

“Abbott Alinity m HCV AMP Kit Recall: False Positive Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56991-abbott-alinity-m-hcv-amp-kit-recall-false-positive-results. Based on FDA recall #Z-0407-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0407-2024%22&limit=1).

The FDA announced on 2023-10-30 that Abbott Molecular, Inc. is recalling Alinity m HCV AMP kits due to risks of false positive results in patient samples. The agency issued recall number Z-0407-2024 for the Class II voluntary recall.

How to tell if you have it

Brand: Abbott
Product: Alinity m HCV AMP kit
REF Numbers: 08N50-095, 08N50-090
Lot Numbers (REF 08N50-095): 381582, 382448, 383204
Lot Numbers (REF 08N50-090): 383203, 385720, 381581, 382447
Units affected: 1,881

The hazard

According to the FDA, Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the identified lots. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay used to detect and quantitate hepatitis C virus (HCV) RNA.

Context

GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls on record since 2021-08-04. Other recent recalls of similar products include Abbott Alinity m Resp-4-Plex AMP Kit Recall (2025-04-28), Abbott Alinity m System Recall (2025-03-20), and Abbott Alinity m STI AMP Kit Recall (2024-09-12). Other recent recalls of similar products include Hologic Aptima HPV Assay Kit Recall (2026-02-18), Abbott ID NOW Influenza A & B 2 Kit (2026-02-09), and Siemens Atellica CH Urine Albumin Recall (2026-07-06).

How to tell if you have this one

Check the product list numbers: 08N50-095 or 08N50-090. Look for specific lot numbers listed for each model: 381582, 382448, 383204 for model 08N50-095 and 383203, 385720, 381581, 382447 for model 08N50-090.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the list number and lot numbers on the kit to confirm if it's affected.

How this recall unfolded

Recall timeline

FDA published this recall 37 days after the firm started it.

Oct 30, 2023Firm started the recall
Nov 29, 2023FDA classified it Class II
Dec 6, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56991-abbott-alinity-m-hcv-amp-kit-recall-false-positive-results">Abbott Alinity m HCV AMP Kit Recall: False Positive Results Risk (GovInfoNow)</a>

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-0407-2024 (October 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0407-2024 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.