Health product recall

Oragene DNA collection device (2019-06-28)

Starting date:
June 28, 2019
Posting date:
July 19, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70467

Last updated: 2019-07-19

Affected Products

Oragene DNA collection device

Reason

During an internal investigation, it was discovered that the ink on the Oragene DNA collection device tube label from the affected lots could potentially smudge when handled by firmly rubbing on the label. If not properly handled, information on the label may deteriorate over time and impact sample traceability.

Affected products

Oragene DNA collection device

Lot or serial number

WE21
WE24

Model or catalog number

OG-600
OG-610

Companies
Manufacturer

DNA Genotek INC.

3000 - 500 PALLADIUM DRIVE

Ottawa

K2V 1C2

Ontario

CANADA