cobas¿ EGFR Mutation Test epidermal growth factor receptor — Class III medical device recall Z-1320-2015
Terminated recall by Roche Molecular Systems, Inc., reported 2015-04-01. False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test,
| Recall number | Z-1320-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2015-01-13 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-12-11 |
| Quantity | 190 kits |
Product
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Reason for recall
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1320-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.