FDA Device recall 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…
- FDA Device
- Class III
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class III recall of West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG… by Focus Diagnostics, citing the firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0182-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-03 |
| Published | 2012-11-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Focus Diagnostics |
| Distribution | US |
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
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Identifiers
| code_info | Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Well…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0182-2013%22
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