BECKMAN COULTER, INC. DxC 500i and DxI 9000 recall in Canada: performance issues
In plain language
This recall involves DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer medical devices sold in Canada. They are being recalled because a software issue may prevent correct application of dilution factors, leading to inaccurate patient results. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module
Model: C11137
Lot: More than 10 numbers, contact manufacturer.
DxI 9000 Access Immunoassay Analyzer
Model: C13252
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Inaccurate test 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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: C11137, C13252
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?
Inaccurate test results
What should consumers do?
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?
Yes, there may be a health risk. Inaccurate test results
When was this product recalled?
This product was recalled on September 26, 2025.
Is the BECKMAN COULTER, INC. brand affected by this recall?
Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer medical devices sold in Canada. They are being recalled because a software issue may prevent correct application of dilution factors, leading to inaccurate patient results. Healthcare professionals should contact the manufacturer for more information.