BEUDAMED
    FDA Recall Open, Classified

    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

    Recall: Z-1113-2025 · Initiated January 6, 2025

    Recall

    Recall Number
    Z-1113-2025
    Event Number
    96107
    Firm
    Sysmex America, Inc.
    FEI Number
    3009711478
    Product Code
    PER
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 6, 2025
    Posted
    February 5, 2025
    Address
    577 Aptakisic Rd, Lincolnshire, IL, 60069-4325

    Description

    Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

    Reason

    Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

    Action

    A Product Notification Field Correction letter was sent to customers beginning 1/6/25. Actions: 1. Until a Sysmex representative contacts you, please do not use the instrument running PS-10 software version 1.5 or 1.6 unless it is used only to create cocktails. 2. Review the content of this communication with your facility's physician and/or pathologist and retain this letter for any future reference. 3. Please fill out the form below and email it back to Sysmex using the email address: [email protected] Questions If you have any questions concerning this information, please contact the Technical Assistance Center at 1- 888-879-7639 An additional Product Notification Field Correction letter was sent to customers beginning 4/9/25. Software Correction The probe washing processes have been updated to incorporate essential washing steps during antibody pipetting. The PS-10 antibody pipetting washing sequence has been reinstated, ensuring a washing step is performed when switching between antibody vials. This update prevents any potential carry-over between antibody reagents. This correction addresses the potential risk of antibody carryover, as detailed in Field Correction Notice CF-08823, released in December 2024. Action 1. Please distribute this product notification as appropriate to your laboratory staff. 2. File this product notification as a part of your laboratory s quality system as required. Questions If you have questions concerning this information, please message the Sysmex Technical Assistance Center (TAC). Simply click on the support tab on the home page of the CRC, click the Create New Issue button under Help Me to send your question to TAC. Choose Technical Assistance-Equipment in the dropdown to complete the form and submit it. Sending a message to TAC is recommended for non-urgent requests. For Canadian customers, please note messages to TAC are only processed in English. For urgent requests, contact the Technical Assistance Center at 1-8

    Distribution

    US Nationwide.

    Quantity

    32 units