Device 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
Z-0108-2020
Product summary
- Event
- Event 83758
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,494 units
- Official record key
device-enforcement:Z-0108-2020
Official wording
Reason: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Code information: All serial numbers
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference