FDA Device recall Z-0909-2018
cobas 6000 Modular Series system
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of cobas 6000 Modular Series system by Roche Diagnostics, citing A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during main….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0909-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-18 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
Reason
A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
Identifiers
| code_info | Serial numbers: 0948-27 0933-27 1214-11 1297-08 0947-23 0932-23 1113-22 16U0-02 16Z4-02 1246-12 1255-08 14F9…Serial numbers: 0948-27 0933-27 1214-11 1297-08 0947-23 0932-23 1113-22 16U0-02 16Z4-02 1246-12 1255-08 14F9-15 14F9-16 14M9-15 14M9-16 0963-17 0949-12 0967-13 0953-28 1741-10 14A3-14 14D5-01 14D5-17 14K0-17 1163-13 1163-14 1146-13 1146-14 1166-18 1149-18 1146-15 1148-16 1113-25 1113-26 1157-01 1157-02 1113-13 1113-14 16Z6-02 0809-22 0888-22 0762-15 0770-07 0756-15 0770-14 0756-22 0825-28 0806-28 1175-11 1161-11 0809-29 0888-29 15K6-10 15U2-10 0626-07 0748-13 0749-10 0629-12 0747-01 14J2-18 1243-13 1247-09 14D7-16 14D7-18 14K3-16 14K3-18 14C0-06 14G5-18 14F9-18 14G3-19 14M9-18 14P2-19 14E2-01 14F0-12 14K9-01 14M1-12 0956-15 0941-30 1151-17 1151-18 1123-17 1123-18 0956-06 1147-03 1147-15 1147-16 1112-02 1113-21 0955-29 0941-14 14D8-04 14D8-05 14K5-04 14K5-05 14E4-09 14D8-01 14K5-01 1184-04 1184-05 1174-06 1174-07 0955-21 0955-27 0940-27 0941-12 0813-21 0813-29 0893-22 0893-30 079 |
|---|
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-0909-2018%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.