Z-0083-2022Class II

cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

Name: Z-0083-2022 cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Creator: Roche Molecular Systems, Inc.
Published: 2021-09-03
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2021-09-03 / Open, Classified

FDA source

Roche Molecular Systems, Inc. began a recall of cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 on 2021-09-03. FDA classified it as Class II and gives the reason as "False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0083-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-03
Posted: 2021-10-08
Recalling firm: Roche Molecular Systems Inc
Product: cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Product code: OWD Somatic Gene Mutation Detection System
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 root cause: Under Investigation by firm
Action: Roche 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 [email protected]. " 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 commerce: 507 US; 6,676 ex- US
Distribution: Worldwide 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.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0083-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0083-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-20	2021-10-08

Product code OWD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)