FDA Device recall Z-1830-2016
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use by Roche Molecular Systems, citing an error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cf….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1830-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-15 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Molecular Systems |
| Distribution | n/a |
Product
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Reason
An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
Identifiers
| code_info | EGFR v2: 07248563190 cfDNA: 07247737190 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 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-1830-2016%22
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