Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Idylla INSTRUMENT Recalled by Biocartis Nv Due to False-positive MSI-H results generated by the Idylla MSI...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biocartis Nv directly.
Affected Products
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.
Quantity: 8 units
Why Was This Recalled?
False-positive MSI-H results generated by the Idylla MSI Test.
Where Was This Sold?
This product was distributed to 5 states: AL, CA, NJ, OH, TX
About Biocartis Nv
Biocartis Nv has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report