FDA Device recall Z-0108-2020
cobas c 311
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of cobas c 311 by Roche Diagnostics Operations, citing tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0108-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-28 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Reason
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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FDA Device · Class II · 2024-11-27 · Roche Diagnostics Operations - Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine ki…
FDA Device · Class II · 2024-10-02 · Roche Diagnostics Operations - Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502
FDA Device · Class II · 2023-11-29 · Roche Diagnostics Operations
All Roche Diagnostics Operations recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0108-2020%22
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