CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Idylla Instrument, IVD recalled by Biocartis Nv
Biocartis is recalling Idylla Instrument, IVD, distributed in Alabama, California, New Jersey, Ohio, Texas. The recall was initiated on 10 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0836-2025
- FDA event ID
- 96022
- Recalling firm
- Biocartis, Mechelen
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Dec 2024
- FDA classified
- 10 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Dec 2024 | Recall initiated by company | |
| 10 Jan 2025 | Classified by FDA | +31 days |
| 22 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
False-positive MSI-H results generated by the Idylla MSI Test.
Product as listed by the FDA
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.
Where it was distributed
US: AL, NJ, TX, OH, CA
Questions about this recall
Why was it recalled?
False-positive MSI-H results generated by the Idylla MSI Test.
Which lots are affected?
UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
Where was it sold?
US: AL, NJ, TX, OH, CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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