CLASS III Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
West Nile Virus IgG DxSelect" kit recalled by Focus Diagnostics
Focus Diagnostics is recalling West Nile Virus IgG DxSelect" kit, distributed nationwide in the US. The recall was initiated on 3 Oct 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0182-2013
- FDA event ID
- 63387
- Recalling firm
- Focus Diagnostics, Cypress, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Oct 2012
- FDA classified
- 31 Oct 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Oct 2012 | Recall initiated by company | |
| 31 Oct 2012 | Classified by FDA | +28 days |
| 7 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
Questions about this recall
Why was it recalled?
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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