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 has been launched to better identify the thermal sensor errors and a new cobas® sars-cov-2 & influenza a/b script to better detect abnormal pcr curves will be made available in due course.Consignees have been notified.The customer issue has been alleged on the cobas liat system, product code: occ, catalog number 07341920190 and udi (b)(4).The test used on the cobas liat system is the cobas sars-cov-2 & influenza a/b test for use on the cobas liat system ((b)(4), product code: qjr).The product catalog number for the test is 09211101190.(b)(4).
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A customer from the united states alleged a discrepant result while using the cobas® sars-cov-2 & influenza a/b nucleic acid test for use on the cobas® liat® system.During a review of the data, several potential false positive runs were identified.Accordingly, 15 mdrs will be filed per fda guidance.Sample 1 was initially alleged by the customer and generated a positive sars-cov-2 and influenza b result.The same sample was repeated on a different instrument which yielded a negative result for all targets.Only the negative results were released.Sample 2-15 were later identified during a data review.Sample 6 generated an influenza b positive result and the remainder of the patient samples all generated positive sars-cov-2 results.An investigation has been performed to evaluate the customer issue.
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