FDA-Device2023-11-29Class II
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)
Roche Diagnostics Operations, Inc.
Hazard
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Sold states
US Nationwide distribution.
Affected count
5,263 kits
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2024Don't want to check this manually?
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