BEUDAMED
    22 results · 44ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 7, 2021

    LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 7, 2021

    LeadCare II Blood Lead Test Kit Catalog Number 70-6762

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 7, 2021

    LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·January 20, 2016

    Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 23, 2017

    Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·November 29, 2014

    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·May 23, 2017

    Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·November 29, 2014

    Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·August 8, 2018

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·January 9, 2018

    LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.

    FDA Recall
    Terminated ·Magellan Diagnostics, Inc.·Product code DOF·January 9, 2018

    Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

    FDA Enforcement
    Class I ·Terminated·Magellan Diagnostics, Inc.·May 24, 2017

    Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010

    FDA Enforcement
    Class I ·Terminated·Magellan Diagnostics, Inc.·May 24, 2017

    Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    FDA Enforcement
    Class I ·Terminated·Magellan Diagnostics, Inc.·June 14, 2017

    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    FDA Enforcement
    Class I ·Terminated·Magellan Diagnostics, Inc.·June 14, 2017

    LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·August 23, 2017

    LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·April 11, 2018

    LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·April 11, 2018

    Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.

    FDA Enforcement
    Class II ·Terminated·Magellan Diagnostics, Inc.·November 7, 2018

    LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004

    FDA Enforcement
    Class I ·Terminated·Magellan Diagnostics, Inc.·July 7, 2021