BEUDAMED
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    EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901

    FDA Recall
    Open, Classified ·Phadia US Inc·Product code MST·May 1, 2023

    Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002

    FDA Recall
    Open, Classified ·Phadia US Inc·Product code MST·May 1, 2023

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

    FDA Recall
    Open, Classified ·Quest International, Inc.·Product code LJB·October 1, 2025

    Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Recall
    Open, Classified ·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025

    Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Recall
    Open, Classified ·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025

    N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297

    FDA Recall
    Open, Classified ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CFN·August 30, 2022

    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

    FDA Recall
    Open, Classified ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code CFN·August 30, 2022

    cobas e801 Immunoassay Analyzer

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

    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code IGG·October 19, 2023

    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

    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

    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620

    FDA Recall
    Open, Classified ·Diasorin Inc.·Product code MYF·December 13, 2023

    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

    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

    FDA Recall
    Open, Classified ·Epitope Diagnostics, Inc.·Product code QKO·October 1, 2020

    V8 Immunodisplacement Kit REF 1803

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code CFF·April 6, 2022

    VIDAS RUB IgG (RBG), REF 30226

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

    VIDAS Measles IgG (MSG), REF 30219

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

    VIDAS Mumps IgG (MPG), REF 30218

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

    HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.

    FDA Recall
    Open, Classified ·Hycor Biomedical Inc·Product code DHR·March 19, 2018