Product Wiki · Recalls · Health Canada — Medical Devices

Oragene DNA collection device (2019-06-28) — recall 44576

Health Canada — Medical Devices · Canada · 2019-07-19 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44576
Date of alert
2019-07-19
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/oragene-dna-collection-device-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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