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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/
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact Mr. Vincent C. Stagnitto
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