Class 2 Device Recall Roche

• Date Initiated by Firm: March 25, 2021
• Create Date: April 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1414-2021
• Recall Event ID: 87622
• Product Classification: Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
• Product: cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
• Code Information: All serial ID numbers
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 US Highway 202 S; Branchburg NJ 08876-3733
• For Additional Information Contact: SAME; 908-253-7200
• Manufacturer 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: 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
• Quantity in Commerce: US: 5,430 units ; OUS 1528 units
• Distribution: Nationwide WorldWide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.