FDA Device recall Z-0083-2022
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
- FDA Device
- Class II
- ongoing
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 by Roche Molecular Systems, citing false Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0083-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-03 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
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
Identifiers
| code_info | All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.