In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer alleged discrepant results for two patients while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.The alleged samples initially generated a negative result for all targets using the cobas® influenza a/b & rsv assay.The same samples were retested on the same cobas liat analyzer using the cobas® sars-cov-2 & influenza a/b assay which yielded a positive result for influenza a.Sample 2 was repeated a total of 3 times on the same liat yielding the same positive result for influenza a.The repeat results were released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 2 mdrs will be filed.
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