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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Molecular Diagnostics Inc.

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  Class 2 Device Recall Roche Molecular Diagnostics Inc. see related information
Date Initiated by Firm April 05, 2016
Create Date July 21, 2016
Recall Status1 Terminated 3 on December 11, 2017
Recall Number Z-2254-2016
Recall Event ID 74221
Product Classification Somatic gene mutation detection system - Product Code OWD
Product cobas EGFR Mutation Test V2
Materials number
CE-IVD: EGFR v2: 07248563190
cfDNA: 07247737190

Device Identifier:
EGFR v2.0: 00875197005448
cfDNA: 00875197005424

Product Usage:
A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).
Code Information Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238
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		 During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Roche Molecular Diagnostics sent an Urgent Field Safety Notice letter dated April 5, 2016 to affected customers. Then letter identified the affected product, problem and actions to be taken. The Instructions for use are provided for the user until new ones are available..
Quantity in Commerce 735 devices EGFR; 509 devices cfDNA
Distribution Foriegn Distribution Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom cfDNA: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom
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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