Class 2 Device Recall Roche

• Date Initiated by Firm: September 03, 2021
• Create Date: October 08, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0083-2022
• Recall Event ID: 88607
• PMA Number: P150047
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• Product: cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
• Code Information: All lot 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: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
• FDA Determined Cause: Under Investigation by firm
• Action: Roche issued Urgent Medical Device Correction letter on 9/3/21 via UPS Ground. Letter states reason for recall, health risk and action to take: Follow the cobas DNA Sample Preparation Kit (catalog number 05985536190) IFU for sample input with regard to the number of FFPET sections and DNA concentration. Follow the cobas cfDNA Sample Preparation Kit (catalog number 07247737190) IFU for plasma samples. " If an Ex20Ins Mutation Detected result is generated with the cobas EGFR Mutation Test v2, you must confirm the result with another method (e.g., sequencing or other PCR-based tests). " Consider reviewing results generated since May 2021. Amivantamab was approved by the U.S. Food and Drug Administration (FDA) for NSCLC patients with EGFR Ex20Ins on May 21, 2021. Test result reports with Ex20Ins Mutation Detected may be considered for confirmatory testing using sequencing or other PCR-based tests, upon the discretion of a CAP/CLIA laboratory director. " Consult with your facility physician and/or pathologist to determine any clinical implications specific to your patients. " Complete all sections of the enclosed faxback form (TP-01381) and fax it to 1-855-208-4038 or email it to Roche8166@sedgwick.com. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-1247 if you have questions about the information contained in this UMDC
• Quantity in Commerce: 507 US; 6,676 ex- US
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.
• 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.

• PMA Database: PMAs with Product Code = OWD