BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0285-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0285-2019
    Event ID
    81074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magellan Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    August 8, 2018
    Classification Date
    October 26, 2018
    Termination Date
    May 12, 2020
    Address
    101 Billerica Ave Bldg 4, N/A, North Billerica, MA, 01862-1271, United States

    Description

    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.

    Reason

    Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.

    Code Info

    Lot 1808M and sub-lots: 1808M-01, 1808M-02, 1808M-03, 1808M-04, 1808M-05, 1808M-06, 1808M-07, 1808M-08, 1808M-09. Exp. Date:November 10, 2019

    Distribution

    Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.

    Quantity

    1,465 kits