BEUDAMED
    FDA Enforcement Class II 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 · Reported August 23, 2017

    Enforcement

    Recall Number
    Z-3035-2017
    Event ID
    77695
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Magellan Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 23, 2017
    Initiation Date
    January 20, 2016
    Classification Date
    August 15, 2017
    Termination Date
    February 21, 2018
    Address
    101 Billerica Ave Bldg 4, N/A, North Billerica, MA, 01862-1271, United States

    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

    Code Info

    Lot # :1507N Exp Date: 1/27/17; Lot # :1508N Exp Date: 2/27/17; Lot # :1510N Exp Date: 4/19/17; Lot # :1511M Exp Date: 5/3/17 Lot # :1511N Exp Date: 5/17/17 Lot # :1512M Exp Date: 6/2/17

    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