Ortho Connect
Brand(s)
Last updated
Summary
Product
Ortho Connect
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ortho Connect | 3.2.1 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Biomedical Data Solutions Limited
Millenium Court, Burton On Trent, Staffordshire, United Kingdom, DE14 2WH
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77428
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