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U.S. Department of Health and Human Services

Class 2 Device Recall Idylla

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 Class 2 Device Recall Idyllasee related information
Date Initiated by FirmDecember 10, 2024
Date PostedJanuary 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0836-2025
Recall Event ID 96022
Product Classification real time Nucleic acid amplification system - Product Code OOI
ProductIdylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
Code Information UDI/DI 05415219000119, Serial Numbers: 00002706, 00002820, 00003103, 00003262, 00003419, 00003434, 00003444, and 00003445.
Recalling Firm/
Manufacturer		 Biocartis Nv
B 3
Generaal De Wittelaan 11
Mechelen Belgium
Manufacturer Reason
for Recall		False-positive MSI-H results generated by the Idylla MSI Test.
FDA Determined
Cause 2		Environmental control
ActionBiocartis 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 Instruments. o For results already obtained using an affected Idylla Instrument, the following apply: o MSS results are VALID and may be reported. o MSI-H (Microsatellite Instability High) results with six or seven positive identified biomarkers (as depicted in the result report) are VALID and may be reported. o MSI-H results other than those with six or seven positive identified biomarkers are INVALID and should NOT be reported or used to manage patient health. Patient samples with these results should be re-tested on an Idylla Instrument that is NOT affected. 2. If you are not the Idylla user, please forward this notice to the Idylla end user or Idylla supervisor and provide Biocartis with the correct contact details for our record keeping. 3. Completion of the Acknowledgement of Receipt (Appendix 2) is required for compliance. Please complete and sign the attached Acknowledgement of Receipt form by December 17, 2024, and send it to vigilance@biocartis.com.
Quantity in Commerce8 units
DistributionUS: AL, NJ, TX, OH, CA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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