Vitros Xt Systems recall in Canada: Performance issues
In plain language
This recall involves Vitros Xt 3400 Chemistry System and Vitros Xt 7600 Integrated System sold in Canada. They are being recalled because a system shutdown may cause shifts in assay results. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
- Check model numbers: Vitros Xt 3400 Chemistry System (VERSION 3.7.2 AND BELOW) and Vitros Xt 7600 Integrated System (VERSION 3.7.2 AND BELOW).
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Affected products
Vitros Xt 3400 Chemistry System
Model: 684 4458
Date codes: VERSION 3.7.2 AND BELOW
Vitros Xt 7600 Integrated System
Model: 6844461
Date codes: VERSION 3.7.2 AND BELOW
Why this matters
Performance issues leading to inaccurate assay 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: VERSION 3.7.2 AND BELOW
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 684 4458, 6844461
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 issues leading to inaccurate assay results
What should consumers do?
Contact the manufacturer if you require additional information. Check model numbers: Vitros Xt 3400 Chemistry System (VERSION 3.7.2 AND BELOW) and Vitros Xt 7600 Integrated System (VERSION 3.7.2 AND BELOW).
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 issues leading to inaccurate assay results
When was this product recalled?
This product was recalled on August 2, 2022.
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 Vitros Xt 3400 Chemistry System and Vitros Xt 7600 Integrated System sold in Canada. They are being recalled because a system shutdown may cause shifts in assay results. Healthcare professionals should contact the manufacturer for more information.