Product Wiki · Recalls · Health Canada — Medical Devices

Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce) — recall 72335

Health Canada — Medical Devices · Canada · 2022-12-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
72335
Date of alert
2022-12-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alinity-m-resp-4-plex-amplific

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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