FDA Device recall Z-1090-2017
cobas p 612 pre-analytical system
- FDA Device
- Class II
- terminated
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of cobas p 612 pre-analytical system by Roche Diagnostics.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1090-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-27 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | TX, WA |
Product
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Reason
Identifiers
| code_info | Serial Number 63004316 63004416 63004516 63002816 63002916 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1090-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.