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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

Product Description 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 meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
Recall Number Z-0182-2013
Classification Class III
Code Info 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.
Product Distributed Qty 425 units
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.

Event Detail

Event Id 63387
Product Type Devices
Status Ongoing
Recalling Firm Focus Diagnostics Inc
City Cypress
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
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