Biocartis Nv recalls Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples…

Recall date

December 10, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0836-2025

FDA classification

Class II

Brand / firm

Biocartis Nv

Sold / distributed

US: AL, NJ, TX, OH, CA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.