BEUDAMED
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    SYNCHRON® AMYLASE (AMY) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code GAT·March 3, 2026

    UNK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code GAT·March 3, 2026

    SOLITAIRE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·January 11, 2024

    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

    CHEMISTRY CALIBRATOR (CHEM CAL)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JIX·December 2, 2016

    ADVIA CHEMISTRY XPT HEMOGLOBIN A1C_3 CALIBRATOR

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JIX·August 18, 2015

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·March 21, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·March 21, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·January 26, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·January 26, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·January 8, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·March 3, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·March 3, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·January 29, 2009

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JIX·February 9, 2009

    H/ ISE STD LOW 10X3ML

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code JIX·April 28, 2014

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JIX·June 10, 2014

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JIX·June 22, 2021

    ADVIA CHEMISTRY HEMOGLOBIN A1C_3 CALIBRATOR

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JIX·October 28, 2014