BEUDAMED
    FDA Enforcement Class III Terminated

    Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.

    Recall: Z-0110-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0110-2013
    Event ID
    63130
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    December 15, 2011
    Classification Date
    October 22, 2012
    Termination Date
    December 28, 2012
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.

    Reason

    The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.

    Code Info

    Lot M002642

    Distribution

    Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Denmark Ecuador Egypt El Salvador Eritrea Ethiopia Finland France French Polynesia Germany Ghana Greece Guatemala Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kenya Kuwait Lebanon Lesotho Libyan Arab Jamahiriya Lithuania Macao Malawi Malaysia Mexico Morocco Namibia Netherlands New Zealand Nigeria Oman Pakistan Panama Paraguay Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saudi Arabia Serbia Singapore Slovakia South Africa Spain Swaziland Sweden Switzerland Taiwan Thailand Tunisia Turkey Uganda United Arab Emirates United Kingdom Viet Nam Zambia Zimbabwe

    Quantity

    5746 units total (2729 units in US)