Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence Recalled by Quidel Corporation Due to One lot of the Sofia 2 Flu +...
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
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
Quantity: 312 Kits
Why Was This Recalled?
One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
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