FDAFDA · Food and drugs·Recall number 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.
Published November 7, 2012 · Recall initiated: October 3, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Focus Diagnostics Inc
- Distributor
- Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.