Recall Z-0352-2024 ยท GHH Fibrin Split Products
Roche Diagnostics Operations, Inc.
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
| Date | Nov 20, 2023 (initiated Oct 3, 2023) |
| Status | Open, Classified |
| Reason | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/3/23 was sent to customers. Actions Required " Roche recommends using citrated plasma for D-Dimer quantification until further notice. " If your laboratory continues to use Li-heparin plasma for D-Dimer quantification, you are required to confirm all results between 0.5 g FEU/mL and 0.675 g FEU/mL with another D-Dimer method or with a citrated plasma sample. " If your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testin |
| Quantity | 5,263 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062203 | TINA-QUANT D-DIMER TEST SYSTEM Roche Diagnostics Corp., Mar 14, 2007 |