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U.S. Department of Health and Human Services

Class 3 Device Recall Roche Molecular Diagnostics

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  Class 3 Device Recall Roche Molecular Diagnostics see related information
Date Initiated by Firm December 18, 2014
Date Posted June 26, 2015
Recall Status1 Terminated 3 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 2		 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.
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