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.
Enforcement
- Recall Number
- Z-1086-2024
- Event ID
- 93799
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Quidel Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 21, 2024
- Initiation Date
- January 3, 2024
- Classification Date
- February 14, 2024
- Address
- 2285 Rutherford Rd, N/A, Carlsbad, CA, 92008-8815, United States
Description
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.
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.
UDI-DI: 30014613339229. Lot: 709083
US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
312 Kits