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.
Other recalls by Roche Molecular Systems
- cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas 5800 instrument, Material No. 08707464001
FDA Device · Class II · 2022-10-26 · Roche Molecular Systems - cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Device · Class II · 2022-04-06 · Roche Molecular Systems
All Roche Molecular Systems recalls
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.