Back to RecallTracker
Health Canada Medical devices

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

Issued December 14, 2022
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
Hazard description
Performance
Product
Product name
Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Reference
ID
RA-72335