Idylla Instrument
Brand(s)
Last updated
Summary
Product
Idylla Instrument
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Idylla Instrument | SER2149 SER3468 SER2361 SER3460 SER3302 SER3321 SER3322 SER2501 | P0010 |
Issue
Biocartis received a complaint on several Idylla MSI test false positive results generated on a single instrument. As part of the investigation, Biocartis conducted a review of the Idylla MSI test performance in the field. A review of all connected runs from 2019 to date identified suspected false positive Idylla MSI test runs obtained by customers in Germany, Italy, Poland, Estonia, Cyprus, and Thailand.
Recall start date: December 9, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Biocartis Nv |
| Generaal De Wittelaan, Mechelen, Belgium, 2800 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76770
Get notified
Receive emails about new and updated recall and safety alerts.