BEUDAMED
    FDA Recall Open, Classified

    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

    Recall: Z-0107-2026 · Initiated September 3, 2025

    Recall

    Recall Number
    Z-0107-2026
    Event Number
    97565
    Firm
    Inpeco S.A. Via San Gottardo 10 Lugano Switzerland
    FEI Number
    3010825766
    Product Code
    CEM
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    September 3, 2025
    Posted
    October 9, 2025

    Description

    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

    Reason

    The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

    Action

    Consignees received an Urgent Medical Device Recall notification via email dated 9/3/25. The notification instructs consignees to not rely on HIL functionality for clinical decision making or to flag potentially erroneous samples. HIL functionality must be discontinued and cannot be disabled by users. Inspeco must send an Inspeco Servicer to consignee locations to disable HIL functionality. Inspeco will contact consingnees to schedule this service. Consignees are to forward the provided notification to those whom it might concern. Consignees with questions can contact Regulatory Affairs via email at [email protected] or Inspeco Service Team via email at [email protected].

    Distribution

    US distribution to CA & NY.

    Quantity

    1 unit