BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-1925-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-1925-2017
    Event ID
    76991
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magellan Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    November 29, 2014
    Classification Date
    May 17, 2017
    Termination Date
    February 26, 2022
    Address
    101 Billerica Ave Bldg 4, North Billerica, MA, 01862-1271, United States

    Description

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

    Reason

    LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

    Code Info

    All serial numbers

    Distribution

    Nationwide Distribution

    Quantity

    49 units