Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0352-2024 — 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)

U.S. FDA — Device Enforcement · United States · 2023-10-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0352-2024
Date of alert
2023-10-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04015630914593
Reported risk: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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