Simplexa Covid-19 Direct Assay
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Simplexa Covid-19 Direct Assay |
12501N, 11269N, 13183N, 12348N, 11784N |
MOL4150 |
Issue
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
Additional information
Details
| Diasorin Molecular LLC |
|
11331 Valley View Street, Cypress, California United States, 90630 |
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