# FDA recall Z-0836-2025

> **Biocartis Nv** · Class II · device recall initiated 2024-12-10.

## 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

- **Recall number:** Z-0836-2025
- **Recalling firm:** Biocartis Nv
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-10
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mechelen, Belgium

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0836-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0836-2025. Source: US FDA. Licensed CC0.

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