Roche Diagnostics Operations, Inc. cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
Roche Diagnostics Operations, Inc. is recalling cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for due to Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026