Biocartis Nv: Medical Device Recall in 2025 - (Recall #: Z-0836-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 10, 2024

Date Posted: January 22, 2025

Recall Number: Z-0836-2025

Event ID: 96022

Reason for Recall:

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

Status: Ongoing

Product Quantity: 8 units

Code Information:

UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.

Distribution Pattern:

US: AL, NJ, TX, OH, CA

Voluntary or Mandated:

Voluntary: Firm initiated