Health product recall

Alinity M System

Last updated

Summary

Product
Alinity M System
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Alinity M System

All lots.

08N53-002

Issue

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.

Recall Start Date: March 22, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Abbott Molecular Inc.

1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75361

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