Z-1602-2024Class II

Alinity m System, Part Number: 08N53-002

Name: Z-1602-2024 Alinity m System, Part Number: 08N53-002
Creator: Abbott Molecular, Inc.
Published: 2024-03-20
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2024-03-20 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Molecular, Inc. began a recall of Alinity m System, Part Number: 08N53-002 on 2024-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1602-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-20
Posted: 2024-04-19
Recalling firm: Abbott Molecular, Inc.
Product: Alinity m System, Part Number: 08N53-002
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Abbott notified consignees on about 03/20/2024 via FedEx letter. Consignees were instructed to ensure the sample tube label requirements. If error code 6013 occurs and uncapped sample tubes are present on the sample rack, one of the following options can be used to resolve the error: 1. Aliquot the sample into another tube permitted by the assay package insert and ensure the sample tube label requirements in Appendix A are met; or 2. Cover colored portion of tube label that is present in the Keep-Out Zone with white opaque material (e.g. white sticker) where the barcode is located. Avoid covering any needed sample information when applying an additional sticker to the sample tube. Or 3. Reach out to the manufacturer of the tube that is triggering the error to discuss alternative tube types that meet the specifications documented within the Abbott assay specific package insert and do not have color within the required color free space (Keep-Out Zone). Consignees were also instructed to review this with appropriate personnel and consignees if further distributed, and to complete and return the response form.
Quantity in commerce: 1,012 units
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, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, LATVIA, LUXEMBOURG, MALAWI, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, MOZAMBIQUE, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, POLAND, PORTUGAL, ROMANIA, RUSSIA (CIS), SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UGANDA, UNITED KINGDOM, VIETNAM, ZIMBABWE.
Product codes and lots: Part Number: 08N53-002; UD/DI: 00884999048034. Not Serial Number specific

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1602-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1602-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-19

Product code OOI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)