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    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 13, 2022

    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 13, 2022

    DxI 9000 Access Immunoassay Analyzer, Part Number C11137

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JLW·September 19, 2025

    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

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JLW·April 23, 2025

    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

    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

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

    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

    The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JLW·August 28, 2024

    Thyroid TSH Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code JLW·November 3, 2025

    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

    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·December 18, 2017