Idylla EGFR Mutation Test (2020-02-22)
- Starting date:
- February 22, 2020
- Posting date:
- March 13, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72571
Last updated: 2020-03-13
Affected Products
Idylla EGFR Mutation Test
Reason
Response to the request from Australia based on a complaint on instructions for use clarity that could potentially lead to a misinterpretation of the limitations and consequently off-label use of the product
Affected products
Idylla EGFR Mutation Test
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Not applicable.
Companies
- Manufacturer
-
Biocartis NV
Generaal de Wittelaan, suite 11B3
Michelen
2800
BELGIUM