Recall Z-0109-2020
Roche Diagnostics Operations, Inc. · initiated August 28, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
Codes / lots: All serial numbers
Reason for recall
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-0109-2020
- Initiated
- August 28, 2019
- Terminated
- October 2, 2020
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Quantity
- 1,086 units
- Distribution
- Nationwide
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0108-2020 Class II | cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference…Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference | 08/28/2019Terminated |