BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code LOM·April 24, 2025

    ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code LOM·April 24, 2025

    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. The VITROS HBeAg test should not be used to test cord blood samples. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code LOM·November 1, 2018

    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code LOM·November 27, 2023

    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code LOM·November 1, 2018

    ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens Material Number (SMN): 10720831

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code LOM·December 22, 2022

    VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code LOM·March 1, 2024

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·June 6, 2025

    Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·March 27, 2025

    Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code MFK·March 27, 2025