Class 3 Device Recall Roche Molecular Diagnostics

• Date Initiated by Firm: December 18, 2014
• Date Posted: June 26, 2015
• Recall Status: Terminated on February 08, 2017
• Recall Number: Z-0999-2015
• Recall Event ID: 70058
• Product Classification: Somatic gene mutation detection system - Product Code OWD
• Product: cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
• Code Information: Lots T10786 T13091, T15435, T15475, T14777, and W00389
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 Us Highway 202 S; Branchburg NJ 08876-3733
• For Additional Information Contact: Mr. Vincent Stagnitto; 908-253-7200
• Manufacturer Reason for Recall: cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
• FDA Determined Cause: Device Design
• Action: RMS issued an Urgent Field Safety Notice on 12/18/2014. A Quality Notification was provided to all users of the of cobas KRAS Mutation Kit CE-IVD, lots T13091, T15435, T15475, T14777, and W00389, informing them of the issue and instructing them to discontinue use and discard any remaining inventory immediately.
• Quantity in Commerce: 660 pieces
• Distribution: Foreign Distributed.
• 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.