Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part… — Class II medical device recall Z-2477-2019
Terminated recall by Roche Diagnostics Operations, Inc., reported 2019-09-11, distributed in AK, CA, FL, HI, IN, KS, KY, LA…. Quality issue with high pressure solenoid valves
| Recall number | Z-2477-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-07-18 |
| Classified | 2019-09-05 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-06-15 |
| Distributed | AK, CA, FL, HI, IN, KS, KY, LA, MD, MO, MT, NY, OH, OR, TX |
| Quantity | 19 units |
| Serial numbers | 1126-03, 1139-04, 1139-05, 1139-06, 1237-10, 1390-03, 14C2-04, 15B3-05, 1943-01, 1943-02, 1943-03, 1943-04, 1943-05, 1943-06, 1943-07, 1943-08, 1943-09, 1943-10, 19P2-01, 8000ISE |
| Model numbers | 05641489001, 05964075001, 06473245001 |
Product
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Reason for recall
Quality issue with high pressure solenoid valves
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2477-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.