BEUDAMED
    FDA Recall Terminated

    Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

    Recall: Z-2687-2020 · Initiated July 6, 2020

    Recall

    Recall Number
    Z-2687-2020
    Event Number
    85959
    Firm
    Sysmex America, Inc.
    FEI Number
    3009711478
    Product Code
    PER
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 6, 2020
    Terminated
    May 21, 2021
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325

    Description

    Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.

    Reason

    Insufficient amount of antibody without an error message or alarm

    Action

    Sysmex issued a field corrective action on July 6, 2020. The product notification states the following actions to be taken: 1. A Sysmex Service Engineer will be scheduled to adjust the probe height to correct the issue from occurring when using the Sysmex antibody vials. The PS-10 should not be used to perform any testing, other than internal validation, until the adjustment is completed. 2. Discontinue use of non-Sysmex antibody vials in the PS-10 for testing until Sysmex hascompleted the verification, unless your internal procedures ensure the required accuracy of the pipetted volume. 3. Please distribute this Product Notification as appropriate to your laboratory 4. File this Product Notification as a part of your laboratorys Quality System as required For urgent requests, call the Technical Assistance Center at 1-888-879- 7639 in the U.S., or at 1-888-679-7639 in Canada

    Distribution

    US Nationwide distribution including in the states of AL, AZ, MD, WA, FL, IL.

    Quantity

    8 units