Recall Z-0083-2022 ยท OWD Somatic Gene Mutation Detection System
Roche Molecular Systems, Inc.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
| Date | Sep 3, 2021 |
| Status | Open, Classified |
| Reason | False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment |
| 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 |
| Quantity | 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.