Medical device recall in Canada: VITROS systems may malfunction
In plain language
This recall involves VITROS 3600, 5600, and XT 7600 Immunodiagnostic and Integrated Systems sold in Canada. They are being recalled because a malfunction may occur after the system is shut down and restarted. This can prevent the processing of microwell assays until service is performed.
What to do
- Stop using the product immediately.
- Check the serial numbers provided in the official notice.
- Contact Ortho-Clinical Diagnostics Inc. for service.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
VITROS 3600 Immunodiagnostic System
Model: 680 2783
VITROS 5600 Integrated System
Model: 680 2413
VITROS XT 7600 Integrated System
Model: 684 4461
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 model number
Model numbers are typically on the product label or packaging.
Affected models: 680 2413, 680 2783, 684 4461
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?
This recall involves VITROS 3600, 5600, and XT 7600 Immunodiagnostic and Integrated Systems sold in Canada. They are being recalled because a malfunction may occur after the system is shut down and restarted. This can prevent the processing of microwell assays until service is performed.
What should consumers do?
Stop using the product immediately. Check the serial numbers provided in the official notice. Contact Ortho-Clinical Diagnostics Inc. for service.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on March 8, 2019.
Is the VITROS brand affected by this recall?
Yes, VITROS products are affected by this recall. This recall involves VITROS 3600, 5600, and XT 7600 Immunodiagnostic and Integrated Systems sold in Canada. They are being recalled because a malfunction may occur after the system is shut down and restarted. This can prevent the processing of microwell assays until service is performed.