BEUDAMED
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    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·April 10, 2014

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put 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 chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    Nichols Advantage TSH - Third Generation

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code JLW·April 28, 2005

    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JLW·April 10, 2014

    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 20, 2015

    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

    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

    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

    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

    VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JLW·August 15, 2018