Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen Recalled by Quidel Corporation Due to Instructions for use in the package insert for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Quidel Corporation directly.
Affected Products
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Quantity: 10537
Why Was This Recalled?
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Quidel Corporation
Quidel Corporation has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report