Recall Z-0352-2024— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0352-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-03

Class II · Ongoing

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2023-10-03. It names one FDA 510(k) clearance: K062203. 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: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-03
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K062203 — TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.·cleared 2007-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.