Abbott recalls Alinity m System model 08N53-002 due to software issues affecting field service maintenance procedures. Affected units may require specific software updates to prevent improper maintenance.
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Abbott is recalling the Alinity m System model 08N53-002 because of a software issue that could prevent proper field service maintenance. This means the system might not be maintained correctly, potentially leading to operational problems.
The software issue prevents the system from completing field service maintenance and diagnostics procedures correctly. This could lead to improper maintenance, but it does not cause immediate injury or damage under normal use conditions.
Users of the Alinity m System model 08N53-002 are affected. Laboratory technicians and healthcare facilities that use this system for testing are most at risk.
Check for the model number 08N53-002 or serial numbers on the Alinity m System. The product was sold by Abbott Molecular, Inc. starting from the date of manufacture.
Verify the software version on the Alinity m System to ensure it is updated to the latest version compatible with field service procedures.
No, the recall is for a software issue that affects maintenance procedures but does not pose a risk of injury or damage under normal use.
Check the model number or serial number on your system; affected units are model 08N53-002.
Ensure your software is updated to the latest version that supports field service maintenance procedures.
We’ve drafted a message you can send Abbott Molecular to request your refund or repair — edit it as you like.
Subject: Recall Z-0461-2022 — Abbott Molecular Abbott Molecular Hello, I own a Abbott Molecular that is covered by recall Z-0461-2022 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.
