Medical device recall in Canada: VITROS systems may have software anomaly
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 software anomaly could cause incorrect test results for plasma. Healthcare professionals should follow the instructions in the official notice.
What to do
- Review the official recall notice for detailed instructions.
- Ensure modifications to qualitative result text and range settings are correctly retained.
- Contact Ortho-Clinical Diagnostics Inc. for support if needed.
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Affected products
VITROS 3600 Immunodiagnostic System-Instrument
Model: 680 2783, 680 2914
Lot: SW V3.3.3 & below
VITROS 5600 Integrated System-Instrument
Model: 680 2413, 680 2915
Lot: SW V3.3.3 & below
VITROS XT 7600 Integrated System
Model: 684 4461
Lot: SW V3.3.3 & below
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: SW V3.3.3 & below
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 680 2413, 680 2783, 680 2914, 680 2915, 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 software anomaly could cause incorrect test results for plasma. Healthcare professionals should follow the instructions in the official notice.
What should consumers do?
Review the official recall notice for detailed instructions. Ensure modifications to qualitative result text and range settings are correctly retained. Contact Ortho-Clinical Diagnostics Inc. for support if needed.
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 June 19, 2020.
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 software anomaly could cause incorrect test results for plasma. Healthcare professionals should follow the instructions in the official notice.