BEUDAMED
    FDA Enforcement Class I Terminated

    Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    Recall: Z-2225-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2225-2017
    Event ID
    77211
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magellan Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    May 23, 2017
    Classification Date
    June 5, 2017
    Termination Date
    July 8, 2021
    Address
    101 Billerica Ave Bldg 4, N/A, North Billerica, MA, 01862-1271, United States

    Description

    Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.

    Reason

    Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

    Code Info

    All lot codes

    Distribution

    Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM

    Quantity

    171,979 kits (total)= 153,447 (US)and 18532 (OUS)