Quidel Corporation is recalling 312 kits of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) because they were labeled with expiration dates that exceed their authorized shelf life. The test kits and the individual diagnostic cassettes inside are labeled with expiration dates in April and May 2025, but the correct expiration date for both is actually September 12, 2024. Using these diagnostic tests after their true expiration date could lead to inaccurate results when testing for Influenza A, Influenza B, or COVID-19.
Using these test kits past their actual shelf life of September 12, 2024, may lead to incorrect or unreliable test results, which could result in a delayed diagnosis or improper treatment for viral infections. No specific injuries or incidents have been reported, but the error was discovered by a supply chain employee who noticed the labels exceeded FDA-authorized limits.
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Sources: FDA iRES · Raw API Response
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