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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- 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
Related recalls
Same manufacturer · Quidel Corporation
See all →- HighQuickVue Dipstick Strep A Test Recalled for False Positive Results
FDA (Devices) · 2026-05-20
- HighDipstick strep A tests recalled over potential for false positive results
FDA (Devices) · 2025-09-17
- HighMedical diagnostic test kits recalled due to misaligned results window
FDA (Devices) · 2024-05-01
- HighQuidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives
FDA (Devices) · 2024-05-01
- ModerateMicroVue C1-Inhibitor Plus EIA kits recalled for potential test failure
FDA (Devices) · 2023-04-05
Same hazard · mis labeling
See all →- ModerateEl Ruisenor De Mexico Recalls Soybeans for Undeclared Soy Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Textured Soy Protein for Undeclared Soy
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Black Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Wheat Bran for Undeclared Wheat Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- ModerateQuidel Recalls Sofia SARS Antigen FIA Package Inserts for Labeling Errors
FDA (Devices) · 2020-10-28
- HighQuidel Recalls Sofia Influenza A+B FIA Kits Due to False Positives
FDA (Devices) · 2013-02-20
- HighQuidel SARS Antigen Test Kits Recalled for False Positive Results
FDA (Devices) · 2020-11-18
- LowRoche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates
FDA (Devices) · 2016-07-20
- Highcobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results
FDA (Devices) · 2021-09-29
- HighDASH COVID and flu tests may give a false negative result
FDA (Devices) · 2025-08-13