Food, drugs, devices › Focus Diagnostics Inc

Device recall: Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influ

FDA enforcement event 67436 · Class II · initiated 4 Feb 2014 · status Terminated · terminated 1 Nov 2014

DeviceVoluntary: Firm initiated1 product recordCypress, CA

FDA enforcement event 67436 is a device recall by Focus Diagnostics Inc of Cypress, CA, initiated 4 Feb 2014 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 1 Nov 2014. 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

"Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals."

Distribution

"Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1144-2014	Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.	2,175 kits	Class II	Terminated	12 Mar 2014

Context

91%of 2014 device events are Class II1,176 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
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
3 Oct 2012	West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes W	Device	Class III	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: "Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Nov 2014. "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.