Medical device recall in Canada: cobas® pro and cobas® pure
In plain language
This recall involves cobas® pro and cobas® pure medical devices used in healthcare settings in Canada. They are being recalled due to a software malfunction that can affect calibration. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer for additional information.
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Affected products
cobas® c 303 analytical unit versions < 01-04
Model: 09031529001
cobas® pro sample supply unit versions < 03-01
Model: 08464502001, 09205632001
cobas® pure sample supply unit versions < 01-04
Model: 09031537001
cobas® c 503 analytical unit versions < 03-01
Model: 08463662001
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: 08463662001, 08464502001, 09031529001, 09031537001, 09205632001
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 cobas® pro and cobas® pure medical devices used in healthcare settings in Canada. They are being recalled due to a software malfunction that can affect calibration. Healthcare professionals should contact the manufacturer for more information.
What should consumers do?
Contact the manufacturer for 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 February 4, 2026.
Is the ROCHE DIAGNOSTICS GMBH brand affected by this recall?
Yes, ROCHE DIAGNOSTICS GMBH products are affected by this recall. This recall involves cobas® pro and cobas® pure medical devices used in healthcare settings in Canada. They are being recalled due to a software malfunction that can affect calibration. Healthcare professionals should contact the manufacturer for more information.