BEUDAMED
    FDA Enforcement Class II Terminated

    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine

    Recall: Z-2124-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2124-2017
    Event ID
    77138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    April 24, 2017
    Classification Date
    May 22, 2017
    Termination Date
    December 30, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine

    Reason

    Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.

    Code Info

    M609458

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.

    Quantity

    3,158 units total (1,957 units in US)