Reported Nov 7, 2012 · Terminated
West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes…
Focus Diagnostics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Focus Diagnostics Inc · 11331 Valley View St · Cypress, CA · 90630-5366
Is this the product you have?
- 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.
- Lot codes and dates
- 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.
- Amount recalled
- 425 units
Where it was sold
- Nationwide
Why it was recalled
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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