Oragene DNA (2018-06-20)

Starting date:

June 20, 2018

Posting date:

January 6, 2020

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-71991

Last updated: 2020-01-07

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  Reason
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  Affected products

Affected Products

Oragene DNA

Reason

During standard shelf life monitoring program used at DNA Genotek includes accelerated testing to confirm product storage claims. Through this testing, we determined that the products and lots may not perform as intended if stored at the maximum labeled temperature (30°) For longer than 18 months. There is no impact on product performance stored at temperatures 15° To 25° Until the "collect saliva by" or "collect by" date printed.

Affected products