The customer's cobas liat analyzer (s/n(b)(4)) was not recommended to be returned for evaluation and repair.From the inspection of the system¿s data, it was identified that optical interference as the optical path changed during the run, recovering from residuals of run #105 there was a leak that occurred around run #105 and subsequently resulted in alleged run #108 sars positive result to produce a false call.Roche received complaints alleging invalid and/or false positive results with the cobas® sars-cov-2 & influenza a/b test for use on the cobas® liat® system for one or more targets (sars-cov-2, influenza a, influenza b).When reviewing the customer-provided data associated with the reported invalid and false positive results, abnormal pcr curves were observed.Per the on-going investigation, several potential causes for the abnormal pcr growth curves leading to invalids and false positives have been identified.These include tube leaks, abnormal pcr steps, and loose thermal sensor wiring.Overall across the installed base, these issues from product use may occur sporadically.For invalid or false positive influenza results, adverse health consequences are not likely.For invalid sars-cov-2, adverse health consequences are not likely since detectability is high and testing can be performed on alternative platforms.For erroneous positive sars-cov-2 results, there is the possibility of adverse health consequences in high risk individuals.As stated in the instructions for use, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.A cobas liat software update to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves have been launched.The implementation of both the software and the updated script have shown a reduction in the calculated false positive rate.Consignees have been notified.The customer issue has been alleged on the cobas liat system, product code: occ ,catalog number07341920190 ,and udi(b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test product code qjr, catalog number 09211101190 and udi.(b)(4).(b)(4).
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