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U.S. Department of Health and Human Services

Class 3 Device Recall Roche Molecular Diagnostics Inc.

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  Class 3 Device Recall Roche Molecular Diagnostics Inc. see related information
Date Initiated by Firm January 13, 2015
Date Posted March 25, 2015
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = ROCHE
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