Abbott recalls Alinity m System with part number 08N53-002 due to a software defect that may cause incorrect settings in the Amplification Detection clamp. Affected units include all serial numbers of this model.
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
Abbott is recalling the Alinity m System with part number 08N53-002 because of a software defect that can set the Amplification Detection clamp's CLEAN position too high. This issue may lead to incorrect results in laboratory testing if the device is used without proper calibration.
The software defect causes the Amplification Detection clamp's CLEAN position to be set too high, which can lead to incorrect test results. This may affect the accuracy of laboratory tests if the device is used without proper calibration. The issue does not involve physical harm or immediate danger to users.
Laboratory users who own the Alinity m System with part number 08N53-002 are affected. Those using the device for medical testing are most at risk of inaccurate results.
Check for the part number 08N53-002 on the Alinity m System. All units with this part number and any serial number are affected.
Verify the Amplification Detection clamp's CLEAN position setting to ensure it is not set too high.
Yes, if your Alinity m System has part number 08N53-002, it is affected by this recall.
Check for part number 08N53-002 on the Alinity m System; all units with this part number and any serial number are affected.
The recall does not require immediate action, but you should check the device settings to ensure the Amplification Detection clamp's CLEAN position is not set too high.
We’ve drafted a message you can send Abbott Molecular to request your refund or repair — edit it as you like.
Subject: Recall Z-0462-2022 — Abbott Molecular Abbott Molecular Hello, I own a Abbott Molecular that is covered by recall Z-0462-2022 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.
