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 a discrepant result for a single patient while using the cobas sars-cov-2 & influenza a/b nucleic acid test on the cobas liat system.The alleged sample initially generated a positive result for sars-cov-2.The same sample was retested twice on a different cobas liat analyzer which yielded a negative result for all targets.The initial positive result was released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 1 mdr will be filed.
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