Recall Z-0836-2025— Biocartis Nv

Name: FDA recall Z-0836-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-10

Class II · Ongoing

Class II FDA medical device recall by Biocartis Nv, initiated 2024-12-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm: Biocartis Nv
Classification: Class II
Status: Ongoing
Initiated: 2024-12-10
Firm location: Mechelen, Belgium

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.