—#176299

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

FDA product code: DDG — Transferrin, Antigen, Antiserum, Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K003064
Affected lot / code info: All serial numbers

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Roche issued notification to consignees by Urgent Medical Device Correction (TP-00754) sent via UPS (signature required) on 8/28/19. The UMDC will also be available on diagnostics.roche.com. The letter identifies the problem, risk to health and action to take: Be aware of new interference claims that are listed in this UMDC and that the rhEPO Therapy Monitoring Statement will be removed from the Method Sheets. The UMDC will serve as intermediate labeling until the updated method sheets are available. Complete all sections of the enclosed fax form. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions if you have questions

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-08-28
Terminated: 2020-10-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.