Abbott Molecular recalls Alinity m System (Part No. 08N53-002) due to potential for abnormal amplification curves. Affected units may produce inaccurate test results.
There is a potential for abnormal (non-sigmoidal) amplification curves.
Abbott Molecular is recalling its Alinity m System (Part No. 08N53-002) because it may produce inaccurate test results due to abnormal amplification curves. This could lead to incorrect health assessments if used for diagnostic testing.
The device may generate abnormal amplification curves during testing, which can cause inaccurate results. This could lead to incorrect health assessments if the system is used for diagnostic purposes. The issue does not involve physical harm but affects test accuracy.
Users of the Alinity m System for diagnostic testing are affected. Laboratory professionals and healthcare providers using this device for clinical testing are most at risk of inaccurate results.
Check for the model number 08N53-002 and all serial numbers on the Alinity m System. The recall applies to all units sold with this specific part number.
Identify the model number on your Alinity m System to confirm if it is 08N53-002.
The recall applies to Alinity m System with part number 08N53-002.
The device may produce abnormal amplification curves, leading to inaccurate test results.
No action is required beyond checking the model number. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Abbott Molecular to request your refund or repair — edit it as you like.
Subject: Recall Z-0460-2022 — Abbott Molecular Abbott Molecular Hello, I own a Abbott Molecular that is covered by recall Z-0460-2022 from Abbott Molecular. 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.
