Recall Z-0836-2025 ยท OOI Real Time Nucleic Acid Amplification System
Biocartis Nv
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.
| Date | Jan 10, 2025 (initiated Dec 10, 2024) |
| Status | Open, Classified |
| Reason | False-positive MSI-H results generated by the Idylla MSI Test. |
| Root cause | Environmental control |
| Action | Biocartis issued an URGENT - Medical Device Correction notice to its consignees on 12/10/2024 via email. The notice provided the description of the problem, its impact, and requested the following actions be taken: 1. Until your Instrument is serviced, please move forward with the option that applies to your situation: o In case you have another Idylla Instrument available that is not affected, use that Instrument to run the Idylla MSI Test and discontinue running the Idylla MSI Test on the listed Instrument(s). o No new Idylla MSI testing should be performed using the affected Idylla Instr |
| Quantity | 8 units |
| Distribution | US: AL, NJ, TX, OH, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.