---
title: "Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid... — FDA record Z-0836-2025 | Is It on Recall"
description: "False-positive MSI-H results generated by the Idylla MSI Test."
url: https://isitonrecall.com/recall/fda-device-z-0836-2025-idylla-instrument-ivd-ref-p0010-intended-for-the-detection-of-nucleic-acid-targets-in-various-types/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human sampl... — FDA record Z-0836-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Biocartis Nv
- **Quantity**: 8 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0836-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0836-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: AL, NJ, TX, OH, CA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [California](https://isitonrecall.com/state/california/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jan 22, 2025
- **Recall initiation date**: Dec 10, 2024
- **Center classification date**: Jan 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0836-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Biocartis Nv records](https://isitonrecall.com/brand/biocartis-nv/)