Mechelen, Belgium
Biocartis Nv recalls
1 recall recorded since 2018, most recently on 10 December 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 December 2024
- Reason
- False-positive MSI-H results generated by the Idylla MSI Test.
- Distribution
- US: AL, NJ, TX, OH, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0836-2025
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.