Health product recall

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