Class 2 Device Recall Abbott Alinity m System

• Date Initiated by Firm: March 20, 2024
• Date Posted: April 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1602-2024
• Recall Event ID: 94251
• Product Classification: real time Nucleic acid amplification system - Product Code OOI
• Product: Alinity m System, Part Number: 08N53-002
• Code Information: Part Number: 08N53-002; UD/DI: 00884999048034. Not Serial Number specific
• Recalling Firm/ Manufacturer: Abbott Molecular, Inc.; 1300 E Touhy Ave; Des Plaines IL 60018-3315
• For Additional Information Contact: Ray Bastian; 224-361-7000
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.