BEUDAMED
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    ADVIA Centaur XPT Immunoassay System

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 28, 2016

    VITROS Immunodiagnostic Products TSH Reagent Pack

    FDA Recall
    Terminated ·Clinical Diagnostic Systems·Product code JLW·January 11, 2018

    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

    FDA Recall
    Terminated ·Kerr Corporation·Product code ELW·February 21, 2012

    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

    FDA Recall
    Terminated ·Ultradent Products, Inc.·Product code ELW·February 4, 2013

    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JLW·November 28, 2012

    Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    FDA Recall
    Terminated ·Clinician's Choice Dental Products Inc.·Product code ELW·March 18, 2022

    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid

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

    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JLW·November 28, 2012

    IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.

    FDA Recall
    Terminated ·ThyroTec Inc·Product code JLW·January 24, 2007

    Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.

    FDA Recall
    Terminated ·Perkinelmer·Product code JLW·June 27, 2012

    Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·May 10, 2013

    Atellica IM 1600 Analyzer, Material Number 11066000

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·March 7, 2019

    Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·January 2, 2018

    AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JLW·August 13, 2019