BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1906-2019 · Initiated January 10, 2019

    Recall

    Recall Number
    Z-1906-2019
    Event Number
    82920
    Firm
    Bio-Rad Laboratories, Inc
    FEI Number
    3022521
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 10, 2019
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    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).

    Action

    The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers.

    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