FDA-Device2019-10-16Class II
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Roche Diagnostics Operations, Inc.
Hazard
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Sold states
Nationwide
Affected count
6,494 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2020Don't want to check this manually?
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