Health Canada — Medical Devices · Canada · 2021-04-14 · Type II
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Reported risk: Roche identified some erroneous results associated with the cobas Sars-CoV-2 and Influenza A/B Test for use on the cobas Liat System. Invalid and/or false positive results could be generated. Review of customer-provided data associated with the reported invalid and false positive results show abnormal PCR growth curves.
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