Focus Diagnostics Inc

Complete recall history across all FDA and CPSC categories — 11 total recalls

Focus Diagnostics Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (11)

FDA medical device enforcement actions by Focus Diagnostics Inc

Date Product Reason Class
Feb 15, 2017 Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantit... After a submission for CLIA database update from Focus Diagnostics to DiaSori... Class II
Feb 15, 2017 Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting ... After a submission for CLIA database update from Focus Diagnostics to DiaSori... Class II
Feb 10, 2016 Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL14... Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied ... Class II
Feb 10, 2016 Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MO... Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied ... Class I
Feb 10, 2016 Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL14... Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied ... Class I
Oct 2, 2015 Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF145... Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit beca... Class II
Mar 15, 2015 STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies t... Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a... Class II
May 15, 2014 Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 ... Focus Diagnostics is providing an urgent safety notice for a correction to th... Class II
Feb 4, 2014 Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the d... Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV... Class II
Jan 10, 2014 Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics ... Focus Diagnostics is initiating an urgent safety notice correction for Simple... Class II
Oct 3, 2012 West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 12215... The firm recalled due to higher reactivity with some samples in the effected ... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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