Recall Z-1602-2024 ยท OOI Real Time Nucleic Acid Amplification System
Abbott Molecular, Inc.
Alinity m System, Part Number: 08N53-002
| Date | Apr 19, 2024 (initiated Mar 20, 2024) |
| Status | Open, Classified |
| Reason | 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 cou |
| 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 cov |
| Quantity | 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, GERM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.