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U.S. Department of Health and Human Services

Class 2 Device Recall Roche

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 Class 2 Device Recall Rochesee related information
Date Initiated by FirmSeptember 03, 2021
Create DateOctober 08, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0083-2022
Recall Event ID 88607
PMA NumberP150047 
Product Classification Somatic gene mutation detection system - Product Code OWD
Productcobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Code Information All lot numbers
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information ContactSAME
908-253-7200
Manufacturer Reason
for Recall
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
FDA Determined
Cause 2
Under Investigation by firm
ActionRoche issued Urgent Medical Device Correction letter on 9/3/21 via UPS Ground. Letter states reason for recall, health risk and action to take: Follow the cobas DNA Sample Preparation Kit (catalog number 05985536190) IFU for sample input with regard to the number of FFPET sections and DNA concentration. Follow the cobas cfDNA Sample Preparation Kit (catalog number 07247737190) IFU for plasma samples. " If an Ex20Ins Mutation Detected result is generated with the cobas EGFR Mutation Test v2, you must confirm the result with another method (e.g., sequencing or other PCR-based tests). " Consider reviewing results generated since May 2021. Amivantamab was approved by the U.S. Food and Drug Administration (FDA) for NSCLC patients with EGFR Ex20Ins on May 21, 2021. Test result reports with Ex20Ins Mutation Detected may be considered for confirmatory testing using sequencing or other PCR-based tests, upon the discretion of a CAP/CLIA laboratory director. " Consult with your facility physician and/or pathologist to determine any clinical implications specific to your patients. " Complete all sections of the enclosed faxback form (TP-01381) and fax it to 1-855-208-4038 or email it to Roche8166@sedgwick.com. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-1247 if you have questions about the information contained in this UMDC
Quantity in Commerce507 US; 6,676 ex- US
DistributionWorldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OWD
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