The liat analyzer serial number was (b)(6).Although a root cause cannot be definitively identified, the data showed true amplification for the positive results.A result discrepancy can occur when a sample generates a ct value at the limit of detection (lod) of the assay.Additionally, it is possible that the observed discrepancies that did not generate a ct value at the limit of detection are due to workflow contamination.This is a run/workflow-specific issue and the reagent is performing as expected.
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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 six patient samples while using the cobas sars-cov-2 & influenza a/b nucleic acid test on the cobas liat system.The alleged samples initially generated a positive result for sars-cov-2.Fresh samples from the patients were tested on the same cobas liat analyzer which yielded a negative result for all targets.The initial positive results were not released.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 6 mdrs will be filed.
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