BEUDAMED
    FDA Enforcement Class II Ongoing

    remel BactiDrop Acridine Orange, REF 21502, 50 per package.

    Recall: Z-0266-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0266-2025
    Event ID
    95458
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 20, 2024
    Classification Date
    October 30, 2024
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    remel BactiDrop Acridine Orange, REF 21502, 50 per package.

    Reason

    A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

    Code Info

    Lot 733100, Exp. 2025-04-04; UDI-DI 848838000447.

    Distribution

    Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the United Kingdom.

    Quantity

    29 kits