Focus Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 18
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Focus Diagnostics, Inc. makes
Focus Diagnostics, Inc. manufactures diagnostic tests for infectious diseases, including rapid immunoassays for herpes simplex virus (HSV) IgG antibodies, controls for HSV testing, and molecular assays for detecting *Clostridioides difficile*, influenza A/B, and respiratory syncytial virus (RSV). Their portfolio also includes multi-analyte diagnostics for Epstein-Barr virus (EBV) IgG and IgM antibodies, as well as PCR-based tests for JC virus (JCV) antibody detection. The company produces both standalone assays and integrated systems, such as the 3M Integrated Cycler for molecular diagnostics.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with most cleared via the 510(k) pathway. These diagnostics are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 18 devicesFDA recalls
FDA recall records list 12 recalls initiated by Focus Diagnostics, Inc., the earliest on 2007-07-06 and the most recent on 2017-02-15. By recorded status: 12 terminated. The reasons filed fall into these groups: labeling or instructions for use, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 15 Feb 2017 Z-1685-2017 Class II Terminated After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
- 15 Feb 2017 Z-1686-2017 Class II Terminated After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
2016
- 10 Feb 2016 Z-1272-2016 Class I Terminated Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Full distribution text
- 10 Feb 2016 Z-1273-2016 Class II Terminated Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Full distribution text
- 10 Feb 2016 Z-1274-2016 Class I Terminated Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Full distribution text
- 10 Feb 2016 Z-1272-2016 Class I Terminated Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
2015
- 2 Oct 2015 Z-0238-2016 Class II Terminated Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
- 15 Mar 2015 Z-1454-2015 Class II Terminated Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.
2014
- 15 May 2014 Z-1958-2014 Class II Terminated 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.
- 4 Feb 2014 Z-1144-2014 Class II Terminated 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.
Full distribution text
- 10 Jan 2014 Z-0846-2014 Class II Terminated Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.
Full distribution text
Show all 12 recalls
2012
- 3 Oct 2012 Z-0182-2013 Class III Terminated The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
2007
- 6 Jul 2007 Z-1764-2008 Unclassified (pre-2012) Terminated A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
Full distribution text
- 6 Jul 2007 Z-1764-2008 Unclassified (pre-2012) Terminated A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
Frequently asked questions
How many devices does Focus Diagnostics, Inc. have in the registry?
The registry currently lists 18 devices for Focus Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Focus Diagnostics, Inc.'s devices?
Among its 18 most recently registered devices, Focus Diagnostics, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Focus Diagnostics, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Focus Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Focus Diagnostics, Inc.?
FDA recall records list 12 recalls initiated by Focus Diagnostics, Inc., the most recent initiated on 2017-02-15. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Focus Diagnostics, Inc. in the registry?
The most recently registered devices listed for Focus Diagnostics, Inc. include HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950, SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT, PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G and SIMPLEXA FLU A/B & RSV.