Recall Monitor
Health Products

Ortho Connect

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Ortho Connect
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Ortho Connect3.2.1
3.2.3
3.0.1
3.01
3.2.2
3.2.4
3.2		6904412
6904411

Issue

An assay rule was created for profile anti-A that was defined with assay anti-A has a grade between 0 and <= 3+ to hold pending review and to notify. When the result for anti-A was received with a grade of 3+, the result did not trigger the rule as was expected. Recall Start Date: April 1, 2025

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