Class 3 Device Recall Roche Molecular Diagnostics Inc.

• Date Initiated by Firm: January 13, 2015
• Date Posted: March 25, 2015
• Recall Status: Terminated on December 11, 2017
• Recall Number: Z-1320-2015
• Recall Event ID: 70355
• PMA Number: P120019
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• Product: cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
• Code Information: T08661
• FEI Number: 2243471
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 Us Highway 202 S; Branchburg NJ 08876-3733
• For Additional Information Contact: Mr. Vincent C. Stagnitto; 908-253-7200
• Manufacturer Reason for Recall: False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
• FDA Determined Cause: Under Investigation by firm
• Action: RMS notified their customers on 1/13/2015.
• Quantity in Commerce: 190 kits
• Distribution: Foreign
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = OWD