Cobas medical devices recall in Canada: Analyzer settings may deactivate
In plain language
This recall involves Cobas 8000 Core Unit, Cobas C 513 Analyzer, and Cobas Pro Sample Supply Unit medical devices. They are being recalled because a database error can deactivate some analyzer settings. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Cobas 8000 Core Unit
Model: 5641446001
Lot: All software versions
COBAS C 513 ANALYZER
Lot: All software versions
COBAS PRO SAMPLE SUPPLY UNIT
Lot: 1924-01, 1924-02
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: 1924-01, 1924-02, All software versions
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 5641446001
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 8000 Core Unit, Cobas C 513 Analyzer, and Cobas Pro Sample Supply Unit medical devices. They are being recalled because a database error can deactivate some analyzer settings. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return, repair, or dispose of it as instructed.
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 December 31, 2020.
Is the Cobas brand affected by this recall?
Yes, Cobas products are affected by this recall. This recall involves Cobas 8000 Core Unit, Cobas C 513 Analyzer, and Cobas Pro Sample Supply Unit medical devices. They are being recalled because a database error can deactivate some analyzer settings. Stop using the product and follow the return/repair steps in the official notice.