Lower risk Medical device recall · FDA · Published September 12, 2024

Abbott Alinity m HPV Kit Recall: Error Code 9198 Risk

Abbott recalls Alinity m HPV AMP Kit (product codes REF 09N15-095, 09N15-090, 09N15-091) due to potential false negative results from iron leaching in the lysis solution.

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

🇺🇸 FDA recall #Z-0233-2025Medical device Abbott ›

Lower-risk recall

Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Abbott is recalling its Alinity m HPV AMP Kit when used with the Alinity m System because iron leaching from the lysis transfer pump can cause false negative results. This means tests might incorrectly show no HPV infection when it's actually present, which could lead to missed diagnoses. Read more at govinfonow.com/recall/54030-abbott-alinity-m-hpv-kit-recall-error-code-9198-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54030-abbott-alinity-m-hpv-kit-recall-error-code-9198-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0233-2025

Cite this page

“Abbott Alinity m HPV Kit Recall: Error Code 9198 Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54030-abbott-alinity-m-hpv-kit-recall-error-code-9198-risk. Based on FDA recall #Z-0233-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0233-2025%22&limit=1).

The FDA announced on Sept. 12, 2024, that Abbott Molecular Inc. is recalling its Alinity m HPV AMP Kit due to potential positive control errors caused by iron leaching. The recall affects approximately 13,318 units distributed worldwide.

How to tell if you have it

Brand: Abbott
Product: Abbott Alinity m HPV AMP Kit
Product codes: REF 09N15-095, REF 09N15-090, REF 09N15-091
UDI/DI codes: 00884999048614, 00884999047921, 00884999049529
Lots: All Lots

The hazard

The recall addresses an increase in Error Code 9198 (Positive control is non-reactive) for the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Abbott traced certain invalidated positive assay controls to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

Context

GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since Aug. 4, 2021. Recent similar recalls include the Abbott Alinity m Resp-4-Plex AMP Kit recall on April 28, 2025, and the Abbott Alinity m System recall on March 20, 2025. Other recent recalls of similar products include the Hologic Aptima HPV Assay Kit recall (Feb. 18, 2026) and the Diagnostica Stago Asserachrom HPIA Kit recall (Dec. 15, 2025).

How to tell if you have this one

Check the product code on the kit: REF 09N15-095, REF 09N15-090, or REF 09N15-091. These kits are sold with the Alinity m System for HPV testing.

Brand
Abbott
Category
Medical device

FDA recall event · 2 products

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
Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, KAZAKHSTAN, KENYA, LUXEMBOURG, MALAWI, MALAYSIA, MONTENEGRO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TANZANIA, THAILAND, UNITED KINGDOM, AND VIETNAM.

Recall number	Product, codes & lots	Quantity
Z-0233-2025	Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091; a) REF 09N15-095, UDI/DI 00884999048614; b) REF 09N15-090, UDI/DI 00884999047921; c) REF 09N15-091, UDI/DI 00884999049529; All Lots	13318 units
Z-0234-2025	Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;; a) REF 09N17-095, UDI/DI 00884999048591; b) REF 09N17-090, UDI/DI 00884999047945; c) REF 09N17-091, UDI/DI 00884999049277 All Lots	15068 units

Based on the official FDA remedy

What to do — step by step

Check Product Code
Identify the product code on the kit (REF 09N15-095, 09N15-090, or 09N15-091) to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

FDA distribution: “Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) countries of: AUSTRIA, BELGUIM, BULGARIA, CAMBODIA, CANADA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 55 days after the firm started it.

Sep 12, 2024Firm started the recall
Oct 28, 2024FDA classified it Class II
Nov 6, 2024Published 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/54030-abbott-alinity-m-hpv-kit-recall-error-code-9198-risk">Abbott Alinity m HPV Kit Recall: Error Code 9198 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-0233-2025 (September 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0233-2025 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.