Data was provided but did not contain the alleged samples.Based on the provided information, both samples appear to be low titer samples.Samples that are low titer may generate wavering results.Based on the available information, there is no indication of a systemic product problem and the reagents are performing as intended.No systemic product problem was identified for the alleged reagent lot.
|
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 from canada alleged a discrepant result for a two patient while using the cobas® sars-cov-2 & influenza a/b nucleic acid test on the cobas® liat® system.Both patients had two samples collected each.One sample was tested using the cobas sars-cov-2 nucleic acid test for use on the cobas liat system and the other was tested using the cobas sars-cov-2 qualitative assay for use on the cobas 6800/8800 systems.For patient 1, the cobas liat generated a positive result with the cobas 6800 generated a negative result for sars-cov-2.For patient 2, the cobas liat generated a negative result with the cobas 6800 generated a positive result for sars-cov-2.It is unknown which results were reported.No harm was alleged.An investigation was conducted to evaluate the customer issue.Per fda¿s eua guidance, 2 mdrs will be filed.
|