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    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·September 29, 2005

    Video Cystoscope models ECY-1570 and ECY-1570K

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FAJ·July 13, 2017

    VITROS ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS ECi System -- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·August 24, 2011

    VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CDP·March 28, 2006

    VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·August 24, 2011

    Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems. Product Code: 6199960

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code QKO·May 26, 2022

    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 18, 2023

    VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.

    FDA Recall
    Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code NIG·July 16, 2014

    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·October 15, 2021

    VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·February 20, 2019

    VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·February 20, 2019

    Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS 3600, VITROS 5600, and VITROS ECi/ECiQ Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·December 13, 2012

    FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56

    FDA Recall
    Open, Classified ·G & H Wire Company·Product code ECI·December 21, 2023

    Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.

    FDA Recall
    Terminated ·G & H Wire Company·Product code ECI·January 21, 2021

    Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code ECI·August 18, 2011

    VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLI·February 20, 2014

    VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGJ·July 12, 2018

    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code JLW·July 12, 2018

    VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code CFT·July 12, 2018