Recall Z-1414-2021

Reason for recall

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

FDA-determined cause: Unknown/Undetermined by firm

Action taken

Roche issued Urgent Medical Device Correction letter on March 25, 2021. Letter states reason for recall, health risk and action to take: Actions Required " Inform any operators that use the cobas Liat analyzer and/or cobas SARS-CoV-2 & Influenza A/B test of the potential hazards associated with this issue and provide a copy of this UMDC as appropriate. " If you observe an increase in Influenza B positive results that does not match community infection rates, stop testing on the cobas Liat analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973 to determine if a tube leak or other issue has occurred. " If you observe dual- and/or triple-positive results for a particular sample, retest the sample with the cobas SARS-CoV-2 & Influenza A/B test for use with the cobas Liat analyzer using a different cobas Liat analyzer. If you do not have an additional analyzer or if results on the second analyzer disagree with the results from the first analyzer, stop testing on the affected analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973. " Monitor your invalid result rates. If there is a sudden increase or if invalid results are observed repeatedly on a specific cobas Liat analyzer, stop testing on the analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973. " If the Thermal runaway (disable) message appears (as described later in this UMDC) on your cobas Liat analyzer running software version 3.3.0, stop testing on the analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973. " For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat analyzer, follow your laboratorys standard operating procedures to investigate the potential for false positive results. " Complete all sections of the enclosed faxback form (TP-01256) and fax it to 1-866-503-1216 or email it to roche6136@ster