Class II
Medical Device Recall: 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 · December 10, 2024
Reason for Recall
False-positive MSI-H results generated by the Idylla MSI Test.
Distribution
US: AL, NJ, TX, OH, CA
States Affected
AL, CA, NJ, OH, TX
Quantity Affected
8 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0836-2025
Status: ongoing
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