BEUDAMED
    FDA Enforcement Class II Ongoing

    EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

    Recall: Z-1906-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1906-2019
    Event ID
    82920
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    January 10, 2019
    Classification Date
    June 30, 2019
    Address
    6565 185th Ave Ne, N/A, Redmond, WA, 98052-5039, United States

    Description

    EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

    Reason

    User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).

    Code Info

    Software version 1.4, UDI for the software is 03610520562024.

    Distribution

    Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.

    Quantity

    213 devices