FDA recall Z-0352-2024

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)

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2023-10-03

Report date

2023-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2024