BEUDAMED
    FDA Enforcement Class I Terminated

    LeadCare II Blood Lead Test Kit Catalog Number 70-6762

    Recall: Z-1952-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1952-2021
    Event ID
    87992
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magellan Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 7, 2021
    Classification Date
    July 1, 2021
    Termination Date
    October 24, 2023
    Address
    101 Billerica Ave Bldg 4, N/A, North Billerica, MA, 01862-1271, United States

    Description

    LeadCare II Blood Lead Test Kit Catalog Number 70-6762

    Reason

    Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

    Code Info

    Lot Numbers/Expiration Date: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1st expansion 6/21/2021: 2101M - 28JUL22; 2103M - 18AUG22; 2105M - 11SEP22; 2106M - 21JAN22; 2107M - 30SEP22; 2nd expansion 8/30/2021; 2012M Sublots: -08, -09, -10, -11, -12, -13, -14 - 08APR22; 2018M - 06JUN22; 2102M - 30SEP21; 2109M - 15OCT22; 2110M - 29OCT22; 2111M - 31MAY22; 2112M - 13NOV22; 2113M - 30JUN22; 2114M - 17DEC22; 2115M - 29DEC22; 7114M - 17DEC22.

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.

    Quantity

    387,281 kits (48 tests/kit=1,757,040 tests)