West Nile Virus IgG DxSelect" kit Catalog No — Class III medical device recall Z-0182-2013
Terminated recall by Focus Diagnostics Inc, reported 2012-11-07, distributed nationwide. The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher
| Recall number | Z-0182-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Diagnostics Inc, Cypress, CA, United States |
| Recall initiated | 2012-10-03 |
| Classified | 2012-10-31 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2012-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, GR, IL, JP, MX |
| Quantity | 425 units |
| Lot numbers | 121117, 122150, 122155, 122641, 122650, 122859, 510 |
| Model numbers | 122150, 122155, 122641, 122650, 122859, EL0300G, EL0351 |
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.
Reason for recall
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.