Focus Diagnostics recalls
Focus Diagnostics appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2017-04-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pne…
FDA Device · Class II · 2017-04-05 · Focus Diagnostics - Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila
FDA Device · Class II · 2017-04-05 · Focus Diagnostics - Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452,…
FDA Device · Class II · 2016-04-13 · Focus Diagnostics - Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452,…
FDA Device · Class I · 2016-04-13 · Focus Diagnostics - Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL14…
FDA Device · Class I · 2016-04-13 · Focus Diagnostics - Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic
FDA Device · Class II · 2015-11-18 · Focus Diagnostics - STRATIFY JCV DxSelect, Model No. EL1950
FDA Device · Class II · 2015-04-29 · Focus Diagnostics - Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct
FDA Device · Class II · 2014-07-09 · Focus Diagnostics - Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV vir…
FDA Device · Class II · 2014-03-12 · Focus Diagnostics - Simplexa Flu A/B & RSV Direct assay, Model MOL2650
FDA Device · Class II · 2014-02-05 · Focus Diagnostics - West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG…
FDA Device · Class III · 2012-11-07 · Focus Diagnostics