Idylla diagnostic INSTRUMENT recalled due to false-positive MSI-H test results
The Biocartis Idylla INSTRUMENT, an in vitro diagnostic device, has been recalled due to false-positive results in MSI-H testing. These false-positive results could lead to inaccurate diagnoses.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II diagnostic device recall with a verified defect (false-positive test results) that could lead to incorrect diagnoses and treatment decisions. No adverse events have been reported; the hazard is a realistic potential for harm rather than documented injury.
Plain-English summary
The Biocartis Idylla INSTRUMENT (REF P0010) is being recalled because it is generating false-positive results in the Idylla MSI-H Test. The Idylla INSTRUMENT is an in vitro diagnostic device intended to detect nucleic acid targets in various types of human samples using disposable, test-specific Idylla Cartridges.
False-positive test results could lead to incorrect diagnoses and inappropriate medical decisions based on inaccurate test findings.
Eight units of the Idylla INSTRUMENT were distributed in the United States across Alabama, New Jersey, Texas, Ohio, and California. The affected units have the following serial numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445 (UDI/DI 05415219000119).
The recalled product
- 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.
- Manufacturer
- Biocartis Nv
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- UDI/DI 05415219000119
- Serial Numbers: 00002706
- 00002820
- 00003103
- 00003262
- 00003419
- 00003434
- 00003444
- and 00003445.
Distribution
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