Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0108-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 28, 2019

Date Posted: October 16, 2019

Recall Number: Z-0108-2020

Event ID: 83758

Reason for Recall:

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

Status: Terminated

Product Quantity: 6,494 units

Code Information:

All serial numbers

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated