FDA Device recall Z-1320-2015
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- FDA Device
- Class III
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class III recall of cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay by Roche Molecular Systems, citing false positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1320-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-01-13 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | n/a |
Product
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Reason
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Identifiers
| code_info | T08661 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Roche Molecular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1320-2015%22
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