[Recalled] cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 — False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation wh… | FDA 2021-09-03
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 |
|---|---|
| Brand / manufacturer | Roche Molecular Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0083-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 September 2021 |
| EAN / barcode | 07248563190 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Roche Molecular Systems, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.