Official recall record
Ortho Connect
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-05-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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