Biocartis Nv: Device Recall
Recall #Z-0836-2025 · 12/10/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0836-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Biocartis Nv
- Status
- Ongoing
- Date Initiated
- 12/10/2024
- Location
- Mechelen, Belgium
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Reason for Recall
False-positive MSI-H results generated by the Idylla MSI Test.
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.
Distribution Pattern
US: AL, NJ, TX, OH, CA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.