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    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·December 4, 2017

    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·February 8, 2018

    Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    FoundationOne CDx test report

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·August 8, 2019

    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    FoundationOne CDx Test Results

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·October 31, 2018

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·November 11, 2015

    Seattle PAP Plus, MP02260

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZD·April 17, 2023

    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JFH·March 5, 2018

    Seattle PAP Plus, MP02260

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·June 13, 2018

    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    FDA Enforcement
    Class I ·Terminated·Galemed Corporation·January 1, 2020

    *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 6, 2016

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone lndustrielle SEES France·Product code CGA·September 22, 2015

    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

    FDA Recall
    Terminated ·Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan·Product code BZD·May 30, 2019

    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.

    FDA Enforcement
    Class II ·Terminated·Horiba Instruments Inc·February 10, 2016

    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories, Limited·August 14, 2019

    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·July 8, 2015