Vitros® 5600, 3600 and XT Systems recall in Canada: Performance issue
In plain language
This recall involves Vitros® 5600, 3600 and XT Systems sold in Canada. It's being recalled because microwell assay results may be reported without an expired reagent code. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer if you require additional information.
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Affected products
Vitros® 5600 Integrated System
Model: 680 2413, 680 2915
Lot: Not applicable.
Vitros® 3600 Immunodiagnostic System-Instrument
Model: 680 2783, 680 2914
Lot: Not applicable.
Vitros® XT 7600 Integrated System
Model: 6272222, 684 4461
Lot: Not applicable.
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: Not applicable.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 6272222, 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® 5600, 3600 and XT Systems sold in Canada. It's being recalled because microwell assay results may be reported without an expired reagent code. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Contact the manufacturer if you require additional information.
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 January 9, 2025.
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® 5600, 3600 and XT Systems sold in Canada. It's being recalled because microwell assay results may be reported without an expired reagent code. Stop using the product and follow the return/repair steps in the official notice.