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Health Canada Medical devices

Ortho Vision Analyzer

Issued May 9, 2025
Issue
The loading station door unlocks for 20 seconds upon request to load samples or diluents. If the door is not opened within this period, it relocks without triggering a re-inventory since no user access occurred. If the door is opened immediately after the allotted 20-second countdown ends but within the door's auto-relock timeframe, the user will be allowed to load samples, however, re-inventory will not be triggered as the software does not detect that the loading station door was opened. There are no error codes generated for this issue. An inventory event will take place the next time you properly access the loading station. Recall Start Date: April 25, 2025
Hazard description
Performance
Product
Product name
Ortho Vision Analyzer
Reference
ID
RA-77425