Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150 Recalled by Focus Diagnostics Inc Due to The firm recalled due to higher reactivity with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Focus Diagnostics Inc directly.
Affected Products
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.
Quantity: 425 units
Why Was This Recalled?
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Focus Diagnostics Inc
Focus Diagnostics Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report