PlainRecalls
FDA Devices Moderate Class II Terminated

cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

Reported: October 16, 2019 Initiated: August 28, 2019 #Z-0109-2020

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

Details

Units Affected
1,086 units
Distribution
Nationwide
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 1,086 units.
Why was this product recalled?
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Which agency issued this recall?
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0109-2020.