Health product recall

Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)

Last updated

Summary

Product
Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer fi you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalogue number

Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)

526393
525766
381177
527142
525460
531612
526483
527602
527403

03R1120
03R1130
506-10
506-30

Issue

There is a potential for false positive results for flu B and RSV while using the list numbers and lot numbers referenced above associated with the manufacture of these lots. There is also a potential for delayed results when using these lots as reactive negative controls invalidate the sample run. Additional quality control mitigations have been put in place to prevent reoccurrence. All subsequent lots of Alinity m resp-4-plex amp kits are not impacted.

Recall start date: November 23, 2022

Additional information

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

Abbott Molecular Inc.

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

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72335

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