ORTHO VISION Analyzer & ORTHO VISION Max Analyzer (2019-10-02)
In plain language
This recall involves ORTHO VISION Analyzer and ORTHO VISION Max Analyzer medical devices used in Canada. They are being recalled because a software issue could lead to patient samples being processed incorrectly, potentially associating results with the wrong patient. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.
What to do
- Stop using the affected ORTHO VISION Analyzer and ORTHO VISION Max Analyzer immediately.
- Check the model and serial numbers of your devices.
- Contact ORTHO-CLINICAL DIAGNOSTICS INC. for further instructions.
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Affected products
ORTHO VISION Analyzer
Model: 6904577
Lot: More than 10 numbers, contact manufacturer.
ORTHO VISION Max Analyzer
Model: 6904576
Lot: 70002012, 70002013, 70002021, 70002022, 70002027
Why this matters
Incorrect patient 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 lot number
Lot numbers identify specific production batches.
Affected lots: 70002012, 70002013, 70002021, 70002022, 70002027, More than 10 numbers, contact manufacturer.
- 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?
Incorrect patient results
What should consumers do?
Stop using the affected ORTHO VISION Analyzer and ORTHO VISION Max Analyzer immediately. Check the model and serial numbers of your devices. Contact ORTHO-CLINICAL DIAGNOSTICS INC. for further instructions.
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. Incorrect patient results
When was this product recalled?
This product was recalled on October 25, 2019.
Is the ORTHO VISION brand affected by this recall?
Yes, ORTHO VISION products are affected by this recall. This recall involves ORTHO VISION Analyzer and ORTHO VISION Max Analyzer medical devices used in Canada. They are being recalled because a software issue could lead to patient samples being processed incorrectly, potentially associating results with the wrong patient. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.