FDA-Device2025-01-22Class II
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.
Biocartis Nv
Hazard
False-positive MSI-H results generated by the Idylla MSI Test.
Sold states
US: AL, NJ, TX, OH, CA
Affected count
8 units
Manufactured in
B 3, Generaal De Wittelaan 11, Mechelen, Belgium
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2025Don't want to check this manually?
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