Roche Diagnostics Operations, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0352-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: October 3, 2023

Date Posted: November 29, 2023

Recall Number: Z-0352-2024

Event ID: 93282

Reason for Recall:

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

Status: Ongoing

Product Quantity: 5,263 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated