Abbott recalls Alinity m System (part 08N53-002) due to error message when using Copan UTM-RT tubes, which may cause incorrect test results.
The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
Abbott is recalling the Alinity m System (part number 08N53-002) because certain Copan UTM-RT tubes can cause the system to display an error message. This may lead to incorrect test results if the tubes are not properly capped. The recall affects users who have the specific part number and use third-party tubes.
The Alinity m System camera detects if tubes are capped. If a tube is capped but the retention bar is missing from the sample rack, the system shows error 6013. This can happen with Copan UTM-RT tubes, potentially causing incorrect test results.
Users of the Alinity m System with part number 08N53-002 who use Copan UTM-RT 3 mL tubes are affected. Laboratory staff and healthcare professionals using the system are most at risk of incorrect test results.
Check for part number 08N53-002 on the Alinity m System. The recall applies to Copan UTM-RT 3 mL tubes without beads used with this system.
Look for error message 'Error - 6013: Has cap, no retention bar' when using the system with Copan UTM-RT tubes.
Abbott identified an issue with Copan UTM-RT 3 mL tubes causing the Alinity m System to display error 6013, which may lead to incorrect test results.
Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing (part number 3C047N).
No, but check for the error message when using Copan UTM-RT tubes as this may cause incorrect 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-1602-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1602-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
