FDAFDA · Alimentos y medicamentos·N.º oficial Z-0182-2013
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
Publicado el 7 de noviembre de 2012 · Inicio del retiro: 3 de octubre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Focus Diagnostics Inc
- Distribuidor
- Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
- Lote
- Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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