Sofia SARS Antigen FIA recall in Canada: Unapproved claims
In plain language
This recall involves the Sofia SARS Antigen FIA medical device sold in Canada. It's being recalled because the manufacturer distributed advertising with new, unapproved claims about detecting SARS-CoV-2 variants. The device still performs as originally stated for detecting the nucleocapsid protein antigen from SARS-CoV-2.
What to do
- No specific action is required for consumers as the device still functions as originally approved.
- Healthcare professionals should be aware of the unapproved advertising claims.
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Affected products
Sofia SARS Antigen FIA
Model: 20374, 20378
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: 20374, 20378
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 the Sofia SARS Antigen FIA medical device sold in Canada. It's being recalled because the manufacturer distributed advertising with new, unapproved claims about detecting SARS-CoV-2 variants. The device still performs as originally stated for detecting the nucleocapsid protein antigen from SARS-CoV-2.
What should consumers do?
No specific action is required for consumers as the device still functions as originally approved. Healthcare professionals should be aware of the unapproved advertising claims.
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 May 13, 2021.
Is the Sofia brand affected by this recall?
Yes, Sofia products are affected by this recall. This recall involves the Sofia SARS Antigen FIA medical device sold in Canada. It's being recalled because the manufacturer distributed advertising with new, unapproved claims about detecting SARS-CoV-2 variants. The device still performs as originally stated for detecting the nucleocapsid protein antigen from SARS-CoV-2.