Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates
Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall due to incorrect expiration-date labeling on diagnostic device packaging. No illnesses, injuries, or diagnostic failures have been reported. Per the rubric, labeling errors without reported harm are classified as Moderate.
Plain-English summary
Quidel Corporation is recalling Lot 709083 of the Sofia 2 Flu + SARS Antigen FIA, a diagnostic test kit used to detect influenza A, influenza B, and SARS-CoV-2. The recall involves 312 kits distributed nationwide to facilities in Florida, Tennessee, Illinois, Louisiana, New York, and Indiana.
The kits contain packaging with incorrect expiration dates. The pouched cassettes are labeled with an expiration date of May 31, 2025, but the correct expiration date is September 12, 2024. The outer kit boxes are labeled with an expiration date of April 30, 2025, but the correct expiration date is also September 12, 2024. The discrepancy was discovered on November 28, 2023, by a supply chain employee who identified that the labeled expiration dates exceeded the FDA-authorized shelf life.
Any healthcare facility or laboratory that received this lot should immediately verify the lot number (709083) against their inventory. Affected kits should not be used for patient testing, as using test kits beyond their authorized shelf life may compromise diagnostic accuracy. Users should contact Quidel Corporation for instructions on proper disposition and replacement of recalled kits.
The recalled product
- Product
- 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 differ
- Manufacturer
- Quidel Corporation
- Affected units
- 312
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 30014613339229. Lot: 709083
Distribution
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