Recall Z-0182-2013— Focus Diagnostics Inc
Class III · Terminated
Class III FDA medical device recall by Focus Diagnostics Inc, initiated 2012-10-03, terminated 2012-12-04. It names one FDA 510(k) clearance: K031953. 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..
- Recalling firm
- Focus Diagnostics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-10-03
- Terminated
- 2012-12-04
- Firm location
- Cypress, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.