FDAOctober 3, 2023device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
What to do
FDA enforcement status: Ongoing
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
04015630914593076133361336510300124532208105618190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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