Device 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)

Z-0352-2024

October 03, 2023

Class II

Product summary

Firm: Roche Diagnostics Operations, Inc.
Event: Event 93282
Status: Ongoing
Classification: Class II
Quantity: 5,263 kits
Official record key: device-enforcement:Z-0352-2024

Official wording

Reason: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

Code information: All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.