FDA recall Z-0836-2025

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 for recall

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

Distribution

US: AL, NJ, TX, OH, CA

Key facts

Status

Ongoing

Initiation date

2024-12-10

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mechelen, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2025