ORTHO VISION Analyzer
Brand(s)
Last updated
Summary
Product
ORTHO VISION Analyzer
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 VISION Max Analyzer | More than 10 numbers, contact manufacturer. | 6904576 |
| ORTHO VISION Analyzer | More than 10 numbers, contact manufacturer. | 6904577 |
Issue
During an internal investigation Quidelortho™ identified a potential for a false positive test result due to carryover of ORTHO Sera Anti-D (DVI) on vision analyzers.
Recall Start Date: November 8, 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-76567
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