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Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various...

FDA Recall #Z-0836-2025 — Class II — December 10, 2024

Recall #Z-0836-2025 Date: December 10, 2024 Classification: Class II Status: Ongoing

Product Description

Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

Reason for Recall

False-positive MSI-H results generated by the Idylla MSI Test.

Recalling Firm

Biocartis Nv — Mechelen

Classification

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

Product Type

Devices

Product Quantity

8 units

Distribution

US: AL, NJ, TX, OH, CA

Code Information

UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.

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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