FDA recall Z-0108-2020

Roche Diagnostics Operations, Inc. · Class II · device

Product

cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

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-0108-2020