BEUDAMED
    FDA Enforcement Class II Terminated

    Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

    Recall: Z-2332-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2332-2021
    Event ID
    88339
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    July 15, 2021
    Classification Date
    August 23, 2021
    Termination Date
    June 4, 2024
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

    Reason

    There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

    Code Info

    Software Version 2.0 and 2.1

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe.

    Quantity

    180 units