Product Wiki · Recalls · Health Canada — Medical Devices

Simplexa Covid-19 Direct Assay — recall 63807

Health Canada — Medical Devices · Canada · 2022-01-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63807
Date of alert
2022-01-10
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: It was recently internally identified that five (5) lots of Simplexatm COVID-19 direct (Ref MOL4150) were shipped to Canada that had been manufactured with the recombinant hot start polymerase produced by Diasorin S.P.A. instead of the enzyme from an external supplier. While the validation for the material made by Diasorin S.P.A. had been successfully completed, the change had not yet been approved by Health Canada for use in products shipped to Canada patient results are not impacted by this compliance related issue. Recall start date: Jan 7, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/simplexa-covid-19-direct-assay

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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