BEUDAMED
    212 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: Cytomegalovirus (CMV) IgM Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM Rubella Virus IgM Toxoplasma gondii IgM

    FDA Recall
    Terminated ·Bio-rad Laboratories, Inc.·Product code JJY·April 15, 2013

    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·September 29, 2005

    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

    Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code LOL·December 17, 2018

    SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA Exp. Date: May 11. BIORAD***CMV IgM EIA For the detection of CMV IgM Antibodies Xn-HARMFUL Cat. No. 25178 96 Test Set Store 2-8 C ID: grey For In Vitro Diagnostic Use*** Contents: I CMV IgM Microplate (96 wells), 1 Negative Control* (0.6 mL), 1 Positive Control (0.6 mL), 1 Substrate (12 mL), 1 Stop Reagent (12 mL), 2 Conjugate* (12 mL), 1 Calibrator 1* (0.6 mL), 1 Calibrator 2* (0.6 mL) , 1 Diluent* (25 mL), 1 Wash Concentrate* (30 mL), *0.1% Sodium Azide Lot No. E1700 Distributed by: Bio-Rad Laboratories-Redmond, WA 98052.

    FDA Recall
    Terminated ·Quest International, Inc.·Product code LKQ·September 28, 2010

    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CFN·January 15, 2015

    AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

    FDA Recall
    Completed ·Hycor Biomedical Inc·Product code DHR·February 21, 2018

    IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc.·Product code LFX·October 21, 2009

    IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc.·Product code LFX·October 21, 2009

    Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date:***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents.***Manufacturer***Diamedix***A Subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 USA-1-800-327-4565***Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not bee established for use in neonates, infants, or on cord blood, and immunocompromised patients.

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LGC·January 16, 2012

    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

    american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.

    FDA Recall
    Terminated ·Louisville Apl Diagnostics Inc·Product code MID·August 10, 2004

    Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code LOL·October 28, 2019

    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

    PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)

    FDA Recall
    Terminated ·Phadia US Inc·Product code MID·August 2, 2012

    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHR·May 10, 2019

    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