BEUDAMED
    FDA Recall Terminated

    Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.

    Recall: Z-1741-2020 · Initiated May 17, 2019

    Recall

    Recall Number
    Z-1741-2020
    Event Number
    84918
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 17, 2019
    Terminated
    March 11, 2022
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.

    Reason

    Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.

    Action

    The recalling firm issued letters dated 5/8/2019 on 5/17/2019 informing the customers of the issue and that a spilled sample could lead to exposure of biohazardous material and that a software update would be made by their field service engineers at the next service call.

    Distribution

    Distribution was made to AL, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, MI, NC, ND, NJ, NY, OH, OR, PA, SD, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Australia, Canada, China, Czech Republic, Egypt, France, Germany, India, Italy, Republic of Korea, Kuwait, Malaysia, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey, UAE, United Kingdom, and Viet Nam.

    Quantity

    291 units