Device recall: Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 – Simplexa" Flu A/B & RSV Direct. The Focus…

Class II FDA enforcement event 68347. Recall start date: 15 May 2014. Status in the FDA record: Terminated. Termination date: 31 Dec 2014.

Reason for recall, in the words of FDA

Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.

Class II, in the words of FDA

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

Focus Diagnostics Inc started this device recall on 15 May 2014. The firm address in the FDA record is in Cypress, CA. FDA put the recall in Class II. FDA event 68347 has 1 product record. The first FDA enforcement report date is 9 Jul 2014. The record gives the status Terminated, with the termination date 31 Dec 2014.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution

Recalling firm

Focus Diagnostics Inc, Cypress, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 68347: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1958-2014	Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 – Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B…	614 kits	Class II	Terminated	9 Jul 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of 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
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
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

Focus Diagnostics Inc: all 8 events

Official channels

FDA enforcement report Z-1958-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 68347. https://recallregister.com/fda/ii/68347/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution
What quantity of product is in FDA event 68347?: The FDA record gives this quantity: 614 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.