BEUDAMED
    150 results · 70ms · Sources: EU EUDAMED, US FDA

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    RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CHL·April 4, 2006

    RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CHL·April 4, 2006

    ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

    Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code LEG·September 8, 2006

    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code GKL·March 16, 2006

    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code JGS·February 17, 2006

    Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code JGS·February 17, 2006

    Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code CHL·January 20, 2006

    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.

    FDA Recall
    Terminated ·Bayer Healthcare, LLC (Diagnostics Division)·Product code JGS·February 17, 2006

    GLUCOMETER DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC/ DIAGNOSTIC DIVISION·Product code CFR·October 27, 2003

    GLUCOMETER DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC/DIAGNOSTIC DIVISION·Product code CFR·November 5, 2003

    ASCENSIA DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC/DIAGNOSTIC DIVISION·Product code CFR·October 7, 2003

    GLUCOMETER DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC. DIAGNOSTIC DIVISION·Product code CFR·October 27, 2003

    GLUCOMETER DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC, DIAGNOSTIC DIVISION·Product code CFR·December 10, 2003

    GLUCOMETER DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC DIAGNOSTIC DIVISION·Product code CFR·November 25, 2003

    GLUCOMETER DEX

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC, DIAGNOSTIC DIVISION·Product code CFR·December 10, 2003