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Focus Diagnostics Inc recalls West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes
Recalled November 7, 2012 · FDA recall Z-0182-2013 · Focus Diagnostics
Hazard
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate. · FDA Class III
Units
425 units
Sold at
Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
Description
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Product
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.
Manufacturer(s)
Focus Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →