Lower risk Medical device recall · FDA · Published March 20, 2024

Abbott Alinity m System: Error 6013 with Copan UTM Tubes

Abbott recalls Alinity m System (part 08N53-002) due to error message when using Copan UTM-RT tubes, which may cause incorrect test results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1602-2024Medical device Abbott ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmAbbott Molecular, Inc.1300 E Touhy Ave · Des Plaines, IL 60018-3315

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/55806-abbott-alinity-m-system-error-6013-with-copan-utm-tubes.

Source Summary by GovInfoNow · govinfonow.com/recall/55806-abbott-alinity-m-system-error-6013-with-copan-utm-tubes · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1602-2024

Cite this page

“Abbott Alinity m System: Error 6013 with Copan UTM Tubes.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55806-abbott-alinity-m-system-error-6013-with-copan-utm-tubes. Based on FDA recall #Z-1602-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1602-2024%22&limit=1).

The FDA announced on March 20, 2024, that Abbott Molecular, Inc. is recalling the Alinity m System (Part Number 08N53-002) due to a hazard involving third-party Universal Transport Medium tubes. The system may generate an error message if the camera detects a cap without a retention bar on the sample rack.

How to tell if you have it

Brand: Abbott
Product: Alinity m System
Part Number: 08N53-002
UD/DI: 00884999048034

The hazard

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 identified this issue with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing (Part Number 3C047N), but other third-party tubes may experience the same issue.

Context

GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since August 4, 2021. Recent similar recalls include an April 28, 2025 Alinity m Resp-4-Plex AMP Kit recall for false positive results risk and a March 20, 2025 Alinity m System recall for liquid spill hazards. Other recent recalls of similar products include an American Contract Systems Convenience Kit recall on June 29, 2026.

How to tell if you have this one

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.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Error Message
Look for error message 'Error - 6013: Has cap, no retention bar' when using the system with Copan UTM-RT tubes.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 42 days after the firm started it.

Mar 20, 2024Firm started the recall
Apr 19, 2024FDA classified it Class II
May 1, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/55806-abbott-alinity-m-system-error-6013-with-copan-utm-tubes">Abbott Alinity m System: Error 6013 with Copan UTM Tubes (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1602-2024 (March 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1602-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.