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
|