Alinity m System, Part Number: 08N53-002

FDA device recall Z-1602-2024 · posted 2024-04-19 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OOI

Quantity affected

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, COLOMBI

Date initiated

2024-03-20

Date posted

2024-04-19

Location

Des Plaines, IL