FDA Enforcement
Class II
Ongoing
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)
Recall: Z-0352-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0352-2024
- Event ID
- 93282
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- October 3, 2023
- Classification Date
- November 20, 2023
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
Description
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)
Reason
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Code Info
All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)
Distribution
US Nationwide distribution.
Quantity
5,263 kits