FDA Device recall Z-2476-2019
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
- FDA Device
- Class II
- terminated
- Published 2019-09-11
On 2019-09-11 the FDA classified a Class II recall of cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 by Roche Diagnostics Operations, citing quality issue with high pressure solenoid valves may cause inaccurate results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2476-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-18 |
| Published | 2019-09-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | AK, CA, FL, HI, IN, KS, KY, LA, MD, MO, MT, NY, OH, OR, TX |
Product
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Reason
Quality issue with high pressure solenoid valves may cause inaccurate results.
Identifiers
| code_info | Serial # : 31A1-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2476-2019%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.