BEUDAMED
    FDA Recall Open, Classified

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    Recall: Z-0921-2025 · Initiated October 7, 2024

    Recall

    Recall Number
    Z-0921-2025
    Event Number
    95785
    Firm
    DRG International, Inc.
    FEI Number
    2245285
    Product Code
    CFP
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 7, 2024
    Posted
    January 15, 2025
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437

    Description

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    Reason

    The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.

    Action

    DRG International began notifying consignees on 10/07/2024 via letter. Consignees were instructed to check inventory for affected units, cease use of them, and quarantine all product. Arrange return of those units. Consignees were also instructed to notify customers if units were further distributed.

    Distribution

    Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.

    Quantity

    10 units