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.
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.
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.
Iron leaching from the lysis transfer pump in the Alinity m System can contaminate the lysis solution. This contamination may cause the positive control to show no reaction (Error Code 9198), leading to false negative HPV test results.
Users of the Alinity m HPV AMP Kit with the Alinity m System are affected. Those performing HPV testing in clinical labs are most at risk of false negative results.
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.
Identify the product code on the kit (REF 09N15-095, 09N15-090, or 09N15-091) to confirm if it's recalled.
Abbott identified an increase in Error Code 9198 (positive control non-reactive) due to iron leaching from the lysis transfer pump in the Alinity m System.
False negative HPV test results could occur, meaning the test might show no HPV infection when it's actually present.
Recalled kits have product codes REF 09N15-095, REF 09N15-090, or REF 09N15-091 when used with the Alinity m System.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0233-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0233-2025 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
