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

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

Distribution pattern: US: AL, NJ, TX, OH, CA