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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1086-2024

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.

Publicado el 21 de febrero de 2024 · Inicio del retiro: 3 de enero de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Quidel Corporation
Distribuidor
US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
Lote
UDI-DI: 30014613339229. Lot: 709083
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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