Focus Diagnostics Inc: Medical Device Recall in 2012 - (Recall #: Z-0182-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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 meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.

Product Classification:

Class III

Date Initiated: October 3, 2012

Date Posted: November 7, 2012

Recall Number: Z-0182-2013

Event ID: 63387

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.

Status: Terminated

Product Quantity: 425 units

Code Information:

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.

Distribution Pattern:

Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated