Product Wiki · Recalls · Health Canada — Medical Devices

Oragene DNA (2018-06-20) — recall 63019

Health Canada — Medical Devices · Canada · 2020-01-06 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
63019
Date of alert
2020-01-06
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/oragene-dna-2018-06-20

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