FDA recall Z-0109-2020
Roche Diagnostics Operations, Inc. · Class II · device
Product
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
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-28
- Report date
- 2019-10-16
- Termination date
- 2020-10-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Indianapolis, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2020