Recall Z-0108-2020 ยท DDG Transferrin, Antigen, Antiserum, Control
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
| Date | Aug 28, 2019 |
| Status | Terminated |
| Reason | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| Root cause | Under Investigation by firm |
| Action | 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 Sup |
| Quantity | 6,494 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003064 | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 Roche Diagnostics Corp., May 1, 2001 |