BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-3035-2017 · Initiated January 20, 2016

    Recall

    Recall Number
    Z-3035-2017
    Event Number
    77695
    Firm
    Magellan Diagnostics, Inc.
    FEI Number
    1218996
    Product Code
    DOF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 20, 2016
    Posted
    August 15, 2017
    Terminated
    February 21, 2018
    Address
    101 Billerica Ave, Bldg 4, North Billerica, MA, 01862-1271

    Description

    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.

    Reason

    LeadCare II Test Kits controls out of range

    Action

    Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..

    Distribution

    Worldwide - US Nationwide distribution and the countries of: COLOMBIA, CANADA, THAILAND, INDIA, UAE, AUSTRALIA, GERMANY, CANADA, SOUTH AFRICA, SPAIN, NEW ZEALAND, KOREA

    Quantity

    12,931 kits