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Recall Observatory FDA recall evidence

Device product

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

Z-0109-2020

August 28, 2019

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 83758
Status
Terminated
Classification
Class II
Quantity
1,086 units
Official record key
device-enforcement:Z-0109-2020

Official wording

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

Code information: All serial numbers

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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