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Simplexa covid-19 direct assay
Official notice
10 Jan 2022
Last checked
10 Jan 2022
An official Health Canada notice concerns Simplexa covid-19 direct assay. 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 Published 2022-01-10.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63807
Official notice
2022-01-10
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Diasorin Molecular, Simplexa Covid-19 Direct Assay.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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