Reported Jan 22, 2025 · Ongoing
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human…
Biocartis Nv
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocartis Nv · B 3 · Mechelen · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI/DI 05415219000119
- Serial Numbers
00002706000028200000310300003262000034190000343400003444and 00003445
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
False-positive MSI-H results generated by the Idylla MSI Test.
This product could cause temporary or reversible health problems — stop using it.
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