FDA Medical devices recall ·
Idylla INSTRUMENT, IVD recall
- Recall number
- Z-0836-2025
- Date
- (initiated December 10, 2024)
- Company / brand
- Biocartis Nv
B 3, Mechelen, Belgium - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
False-positive MSI-H results generated by the Idylla MSI Test.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
Distribution
US: AL, NJ, TX, OH, CA
States: Alabama California New Jersey Ohio Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0836-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.