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Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03...

FDA Recall #Z-0352-2024 — Class II — October 3, 2023

Recall #Z-0352-2024 Date: October 3, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Roche Diagnostics Operations, Inc. — Indianapolis, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5,263 kits

Distribution

US Nationwide distribution.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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