Health Products

Ortho Vision Analyzer

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: Ortho Vision Analyzer
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Ortho Vision AnalyzerMore than 10 numbers, contact manufacturer.6904577
Ortho Vision Max AnalyzerNot applicable.6153434
Ortho Vision Max AnalyzerMore than 10 numbers, contact manufacturer.6904576

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

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