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Luminex Molecular Diagnostics Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
26
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0043-2025Class IINxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468September 5, 2024
Z-0042-2025Class IINxTAG Respiratory Pathogen Panel, REF: I051C0447September 5, 2024
Z-0161-2020Class IIxTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue NumbeJuly 16, 2019
Z-1767-2019Class IIxTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identifFebruary 22, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K242613NxTAG® Respiratory Pathogen PanelOctober 2, 2024
K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)March 11, 2024
K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareDecember 11, 2019
K191161xTAG Gastrointestinal Pathogen Panel (GPP)November 12, 2019
K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)November 4, 2019
K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)November 30, 2018
K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)November 30, 2018
K170492xTAG CYP2D6 Kit v3August 11, 2017
K163347xTAG Cystic Fibrosis 39 Kit v2December 15, 2016
K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRDecember 15, 2016
K152386NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareDecember 17, 2015
K140647XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)October 24, 2014
K140377XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)September 16, 2014
K131565XTAG CYP2C19 KIT V3September 11, 2013
K130189XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)May 21, 2013
K121894XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGMarch 21, 2013
DEN130003XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)January 14, 2013
K112781TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)February 17, 2012
K112199XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)September 1, 2011
K103776XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FASTJuly 1, 2011