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.
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.
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.
The recalled kits have been reported to produce more false positive results, meaning they might incorrectly indicate hepatitis C infection when it's not present. This can lead to unnecessary treatment or delayed care for actual infections.
Healthcare providers using the Alinity m HCV AMP kits for hepatitis C testing are most at risk. Patients who received results from these kits may need to retest.
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.
Verify the list number and lot numbers on the kit to confirm if it's affected.
Abbott has received reports of increased false positive results in patient samples when using these specific kits.
Check the product list numbers and lot numbers to confirm if your kit is affected. If it is, contact Abbott for further instructions.
The kits may produce false positive results, which could lead to unnecessary treatment or missed diagnoses, but the risk is not severe enough to require immediate action.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0407-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0407-2024 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.
