Food, drugs, devices › Focus Diagnostics Inc

Device recall: West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes W

FDA enforcement event 63387 · Class III · initiated 3 Oct 2012 · status Terminated · terminated 4 Dec 2012

DeviceVoluntary: Firm initiated1 product recordCypress, CA

Focus Diagnostics Inc (Cypress, CA) initiated this device recall on 3 Oct 2012; FDA lists 1 product record under event 63387, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 823 device enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 4 Dec 2012. Initiation: voluntary: firm initiated. Focus Diagnostics Inc has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Focus Diagnostics Inc, Cypress, CA.

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."

Distribution

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

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0182-2013	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…	425 units	Class III	Terminated	7 Nov 2012

Context

6%of 2012 device events are Class III823 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Focus Diagnostics Inc

Initiated	Product (first record)	Type	Class	Records
15 Feb 2017	Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella	Device	Class II	2
10 Feb 2016	Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1	Device	Class I	3
2 Oct 2015	Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.	Device	Class II	1
15 Mar 2015	STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitr	Device	Class II	1
15 May 2014	Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagno	Device	Class II	1
4 Feb 2014	Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influ	Device	Class II	1
10 Jan 2014	Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intende	Device	Class II	1

All 8 events for Focus Diagnostics Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Dec 2012. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.