Ortho Vision and Vision Max Analyzer recall in Canada: performance issue
In plain language
This recall involves Ortho Vision and Vision Max Analyzers sold in Canada. They are being recalled because of a performance issue that could lead to false positive test results. Healthcare professionals should review the notice and follow the instructions for continued use.
What to do
- Review the official notice.
- Retain the notice for your lab.
- Return the reply form.
- Only continue use following the supplied directions.
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Affected products
Ortho Vision Analyzer
Model: 6904577
Date codes: Software 5.14.5 and below
Ortho Vision Max Analyzer
Model: 6904576
Date codes: Software 5.14.5 and below
Why this matters
Performance issue leading to false positive results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: Software 5.14.5 and below
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 6904576, 6904577
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Performance issue leading to false positive results
What should consumers do?
Review the official notice. Retain the notice for your lab. Return the reply form. Only continue use following the supplied directions.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Performance issue leading to false positive results
When was this product recalled?
This product was recalled on July 14, 2023.
Is the ORTHO-CLINICAL DIAGNOSTICS INC. brand affected by this recall?
Yes, ORTHO-CLINICAL DIAGNOSTICS INC. products are affected by this recall. This recall involves Ortho Vision and Vision Max Analyzers sold in Canada. They are being recalled because of a performance issue that could lead to false positive test results. Healthcare professionals should review the notice and follow the instructions for continued use.