Although a root cause cannot be identified, the data does not show any abnormalities for the negative result generated by the assay.A result discrepancy may be expected between assays due to potential differences in the tests¿ limits of detection (lod) and intended use.Based on the data analysis review, the product is performing as intended.
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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 patient sample was initially tested positive for sars-cov-2 using an unknown local test.The sample was tested on the cobas liat and generated a negative result for sars-cov-2.Unknown if and which 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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