BEUDAMED
    71 results · 27ms · Sources: EU EUDAMED, US FDA

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    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

    Food Allergy Panel Test (IgE)

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

    Phadia 1000 Instrument, Article Number 12-3800-01.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·July 5, 2017

    Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    Food Sensitivity Test Large

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

    Pet Allergy Test

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

    Food Intolerance Test Large

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

    Food Intolerance Test Medium

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

    Food Sensitivity Test Small

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

    Allergy Test IgE

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

    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·December 18, 2017

    ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·December 18, 2017

    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

    FDA Recall
    Terminated ·Hitachi Chemical Diagnostics Inc·Product code DHB·December 21, 2012

    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

    FDA Recall
    Terminated ·Phadia US Inc·Product code DHB·November 20, 2014

    HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

    FDA Recall
    Open, Classified ·Hycor Biomedical LLC·Product code DHB·July 25, 2018

    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·July 9, 2019

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Recall
    Terminated ·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·November 20, 2017