BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1295-2018 · Reported April 11, 2018

    Enforcement

    Recall Number
    Z-1295-2018
    Event ID
    79279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magellan Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 11, 2018
    Initiation Date
    January 9, 2018
    Classification Date
    April 3, 2018
    Termination Date
    December 11, 2020
    Address
    101 Billerica Ave Bldg 4, N/A, North Billerica, MA, 01862-1271, United States

    Description

    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.

    Reason

    The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.

    Code Info

    Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.

    Distribution

    Worldwide Distribution

    Quantity

    6,143