BEUDAMED
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    Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgM antibodies against measles virus in a patient's serum or plasma Component: not a component

    FDA Recall
    Open, Classified ·Quest International, Inc.·Product code PCL·July 17, 2025

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·April 14, 2022

    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code OHQ·November 6, 2023

    IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code DEW·July 31, 2024

    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code MID·February 28, 2023

    CMV IgM EIA, in vitro diagnostic.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LFZ·October 19, 2022

    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025

    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKO·January 13, 2022

    Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code CFN·May 27, 2024

    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics·Product code JIT·May 8, 2023

    Mycoplasma test, IgG and IgM

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

    VIDAS Lyme IgM II (LYM), REF 416436

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LSR·September 22, 2021

    VIDAS SARS-COV-2 IgM, Ref 423833-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code QKO·September 22, 2021

    Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CFN·December 15, 2023

    cobas e801 Immunoassay Analyzer

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022

    ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G

    FDA Recall
    Open, Classified ·Zeus Scientific, Inc.·Product code MYL·October 31, 2023

    DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code QKO·May 22, 2023

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·March 1, 2024

    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·July 19, 2023

    BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.

    FDA Recall
    Open, Classified ·Leica Microsystems, Inc.·Product code NJT·November 18, 2019