Z-0108-2020 Class II Terminated
FDA device recall Z-0108-2020 was initiated by Roche Diagnostics Operations, Inc. on August 28, 2019 and is designated Class II. Reason for recall: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference The recall status is terminated (terminated October 2, 2020). Affected quantity: 6,494 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 28, 2019
- Termination Date
- October 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,494 units
Product Description
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 for Recall
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Distribution Pattern
Nationwide
Code Information
All serial numbers