FDADecember 10, 2024device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
False-positive MSI-H results generated by the Idylla MSI Test.
What to do
FDA enforcement status: Ongoing
Brands named
biocartis nvbiocartis
UPCs
05415219000119
Recall history
No related federal recalls on record for this brand yet.
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