Ortho Vision Analyzers
Brand(s)
Last updated
Summary
Product
Ortho Vision Analyzers
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 catalogue number |
|---|---|---|
| Ortho Vision Analyzer | More than 10 numbers, contact manufacturer. | 6904577 |
| Ortho Vision Max Analyzer | More than 10 numbers, contact manufacturer. | 6904576 |
Issue
Due to a wash protocol implementation discrepancy, there is potential for carry over of the Anti-S which may impact results of certain tests after pipetting Anti-S reagent. This issue is intermittent because several factors must interact across a series of events for the false positive to occur. The wash protocol will be updated in the next software release.
Recall start date: March 21, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
| Ortho-Clinical Diagnostics Inc. |
| 1001 Us Hwy 202, Raritan, New Jersey, United States, 08869 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75367
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