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

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  Reason
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  Affected products

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