BEUDAMED
    FDA Enforcement Class II Terminated

    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

    Recall: Z-2730-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2730-2017
    Event ID
    77364
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 19, 2017
    Initiation Date
    May 15, 2017
    Classification Date
    July 13, 2017
    Termination Date
    September 9, 2020
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

    Reason

    The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.

    Code Info

    Lot No. 72645074, Exp. Date 30 Apr 2018

    Distribution

    US Nationwide Distribution in the states of AL, AR, AK, CA, CO, DE, FL, GA, ID, IL, IN, IO, KS, KY, LA, MA, MD, MS, MI, ME, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WV, WI, and Puerto Rico Brunei, Canada, China, Czech Republic, France, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, Panama, Paraguay, Philippines, Qatar, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates, & United Kingdom.

    Quantity

    4444 AQUA CAL Level 1 kits