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
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