cobas EGFR Mutation Test v2-Somatic gene mutation detection system… — Class II medical device recall Z-0083-2022
Ongoing recall by Roche Molecular Systems, Inc., reported 2021-10-20, distributed nationwide. False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutatio
| Recall number | Z-0083-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2021-09-03 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DK, DO, EC, ES, FR, GB, GR, HK, HR, HU, ID, IL, IN, IT, JP, KR, LB, LT, MA, MY, NL, NO, NZ, PA, PE, PH, PK, PL, RS, RU, SE, SG, SI, SK, SV, TH, TW, UY, VN |
| Model numbers | 07248563190 |
Product
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.