Product Wiki · Recalls · Health Canada — Medical Devices

Ortho Vision Analyzer — recall 44398

Health Canada — Medical Devices · Canada · 2016-12-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44398
Date of alert
2016-12-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Ortho Clinical Diagnostics (Ortho) has initiated a recall because Ortho confirmed that if incubation time parameters are changed when creating a user defined protocol (UDP) test, then the incubation time of the Ortho test template and other UDP tests created from the same test template may change. The system will update the incubation time with the latest selection for all UDPs that use the same template, and will also update the Ortho test template.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ortho-vision-analyzer

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