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)
Reported: November 29, 2023 Initiated: October 3, 2023 #Z-0352-2024
Product 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 for Recall
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 5,263 kits
- Distribution
- US Nationwide distribution.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Roche Diagnostics Operations, Inc.. Units affected: 5,263 kits.
Why was this product recalled? ▼
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0352-2024.
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