Z-0109-2020 Class II Terminated
FDA device recall Z-0109-2020 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: 1,086 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
- 1,086 units
Product Description
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
Reason for Recall
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Distribution Pattern
Nationwide
Code Information
All serial numbers