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Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31
Recalled November 29, 2023 · FDA recall Z-0352-2024 · Roche Diagnostics Operations
Hazard
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. · FDA Class II
Units
5,263 kits
Sold at
US Nationwide distribution.
Description
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Product
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)
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →