FebriDx recall in Canada: Not authorized for COVID-19 diagnosis
In plain language
This recall involves FebriDx medical devices sold in Canada. It's being recalled because its use for specific COVID-19 diagnosis is not authorized by Health Canada. This notification informs customers that the device is for identifying and differentiating viral from bacterial acute respiratory infection.
What to do
- Stop using the product for COVID-19 diagnosis.
- Contact the manufacturer for more information.
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Affected products
FebriDx
Model: RPS-FDX-CA
Lot: More than 10 numbers, contact manufacturer.
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: RPS-FDX-CA
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 FebriDx medical devices sold in Canada. It's being recalled because its use for specific COVID-19 diagnosis is not authorized by Health Canada. This notification informs customers that the device is for identifying and differentiating viral from bacterial acute respiratory infection.
What should consumers do?
Stop using the product for COVID-19 diagnosis. Contact the manufacturer for more 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 December 31, 2020.
Is the FebriDx brand affected by this recall?
Yes, FebriDx products are affected by this recall. This recall involves FebriDx medical devices sold in Canada. It's being recalled because its use for specific COVID-19 diagnosis is not authorized by Health Canada. This notification informs customers that the device is for identifying and differentiating viral from bacterial acute respiratory infection.