Abbott recalls Alinity m STI AMP Kit (product codes REF 09N17-095, 09N17-090, 09N17-091) due to potential iron leaching causing Error Code 9198. Affected units may need replacement.
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 Alinity m STI AMP Kit products that can cause Error Code 9198 due to iron leaching from the lysis transfer pump. This error may lead to inaccurate test results, but the recall does not indicate immediate safety risks to users.
Iron leaching from the lysis transfer pump in the Alinity m System can contaminate the lysis solution, causing positive control tests to show no reaction (Error Code 9198). This leads to inaccurate test results, but does not pose a direct safety hazard to users.
Users of the Alinity m STI AMP Kit with product codes REF 09N17-095, REF 09N17-090, or REF 09N17-091 are affected. Laboratory staff and healthcare professionals using these kits are most at risk of inaccurate test results.
Check for product codes REF 09N17-095, REF 09N17-090, or REF 09N17-091 on the Alinity m STI AMP Kit. The kits are sold with the Alinity m System and are used for HPV and STI testing.
Identify if your kit has product codes REF 09N17-095, REF 09N17-090, or REF 09N17-091.
Abbott identified an increase in Error Code 9198 (positive control non-reactive) due to iron leaching from the lysis transfer pump.
Error Code 9198 indicates the positive control test failed, which may lead to inaccurate test results for HPV and STI testing.
No, the recall does not require stopping use; it only addresses potential inaccurate test results.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0234-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0234-2025 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.
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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.
