Cobas 6800 & 8800 recall in Canada: Medical device issue
In plain language
This recall involves Cobas 6800 and Cobas 8800 medical devices used in Canada. The manufacturer requested disabling a sensor because it incorrectly detected the diluent container as empty. This recall is for a medical device issue.
What to do
- Follow the instructions provided by the manufacturer or healthcare professional.
- Refer to the official notice for specific guidance.
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Affected products
Cobas 6800
Model: 5524245001
Lot: All lots
Cobas 8800
Model: 5412722001
Lot: All lots
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 5412722001, 5524245001
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 6800 and Cobas 8800 medical devices used in Canada. The manufacturer requested disabling a sensor because it incorrectly detected the diluent container as empty. This recall is for a medical device issue.
What should consumers do?
Follow the instructions provided by the manufacturer or healthcare professional. Refer to the official notice for specific guidance.
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 November 8, 2019.
Is the Cobas brand affected by this recall?
Yes, Cobas products are affected by this recall. This recall involves Cobas 6800 and Cobas 8800 medical devices used in Canada. The manufacturer requested disabling a sensor because it incorrectly detected the diluent container as empty. This recall is for a medical device issue.