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Alinity m recallZ-1602-2024 · Abbott Molecular, Inc. · initiated Mar 20, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Molecular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1602-2024
Status
Open, Classified
Initiated by the company
Mar 20, 2024
Posted by the FDA
Apr 19, 2024
Recalling firm
Abbott Molecular, Inc.
Quantity
1,012 units
Product code
OOI
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 description

Alinity m System, Part Number: 08N53-002

Code information (models, lots, serial numbers)

Part Number: 08N53-002; UD/DI: 00884999048034. Not Serial Number specific

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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