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    Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay

    FDA Recall
    Terminated ·Zeus Scientific, Inc.·Product code N/A·July 22, 2019

    Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·May 7, 2021

    Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·May 7, 2021

    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MYF·February 8, 2021

    Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code CFN·September 11, 2014

    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use

    FDA Recall
    Terminated ·Kamiya Biomedical Company, LLC·Product code JIX·July 19, 2017

    Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code CFN·September 11, 2014

    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·March 31, 2016

    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code MZP·July 7, 2004

    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AmpliCap HCV MonitorTest, Export, RUO.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code MZP·July 7, 2004

    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG CT Detection Kit

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code MKZ·July 7, 2004

    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG NG Detection Kit

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code LSL·July 7, 2004

    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR M. avium Detection Kit, Export,RUO.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·July 7, 2004

    Amplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR NG Detection Kit, Export IVD/CE.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code LSL·July 7, 2004

    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR IC Detection Kit, Export, IVD/CE.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·July 7, 2004

    Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor IC Detection Kit, 96 test [General Purpose]

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·July 7, 2004

    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR MTB Detection Kit, Gen 2 Export IVD/CE.

    FDA Recall
    Terminated ·Roche Molecular Systems Inc·Product code MWA·July 7, 2004

    Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810

    FDA Recall
    Terminated ·Straumann Usa, Llc·Product code EGG·January 10, 2008

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code KGG·October 11, 2013