BEUDAMED
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    DIGOXIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code KXT·March 15, 2024

    DIGOXIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code KXT·March 7, 2024

    VANCOMYCIN TEST SYSTEM

    FDA Adverse Event
    Malfunction ·SERADYN·Product code LEH·December 18, 2007

    COBAS AMPLIPREP/COBAS TAGMAN CMV TEST

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code PAB·June 1, 2015

    VACUETTE® TUBE 4 ML K2E K2EDTA 13X75

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·December 15, 2022

    ATELLICA IM CARCINOEMRYOINIC (CEA)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code DHX·January 11, 2021

    ADVIA CENTAUR XP PSA ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MTF·July 5, 2018

    MCGHAN

    FDA Adverse Event
    Injury ·MCGHAN·Product code FTR·July 25, 2000

    PHARMCHEK SWAET PATCH

    FDA Adverse Event
    Injury ·PHARMCHEM, INC.·Product code FMH·August 26, 2025

    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    IFORIA 3 DR-T DF-1

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·May 3, 2021

    ITREVIA 7 VR-T DX DF-1 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·May 3, 2021

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 16, 2023

    ELECSYS FT4 IV

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·October 30, 2023

    IMPELLA RP FLEX

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code PYX·March 31, 2025

    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·July 11, 2018

    ELECSYS ESTRADIOL III

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CHP·October 24, 2024

    IFORIA 5 VR-T DX PROMRI DF-1

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·October 6, 2020

    INLEXA 3 VR-T DF-1

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·October 8, 2020