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Biocartis Nv recalls Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples
Recalled January 22, 2025 · FDA recall Z-0836-2025 · Biocartis Nv
Hazard
False-positive MSI-H results generated by the Idylla MSI Test. · FDA Class II
Units
8 units
Sold at
US: AL, NJ, TX, OH, CA
Description
False-positive MSI-H results generated by the Idylla MSI Test.
Product
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.
Manufacturer(s)
Biocartis Nv
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →