Z-0836-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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 for Recall
False-positive MSI-H results generated by the Idylla MSI Test.
Distribution Pattern
US: AL, NJ, TX, OH, CA
Code Information
UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.