FDA-Device2019-10-16Class II

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

Roche Diagnostics Operations, Inc.
Hazard

Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

Sold states
Nationwide
Affected count
1,086 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2020

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