BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0266-2025 · Initiated September 20, 2024

    Recall

    Recall Number
    Z-0266-2025
    Event Number
    95458
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JFO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 20, 2024
    Posted
    October 30, 2024
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    The recalling firm issued letters dated 9/18/2024 on 9/20/2024 via first class mail. The letter explained the reason for recall, risk to health, product distribution information, and actions to be taken by the consignee, which included destroying any remaining inventory of the affected lot number and completion and return of the Acknowledgement Form indicating the number of units destroyed. The form was to be returned via email. The notice was to be passed onto all who need to be aware within the consignee's organization or to any organization where the affected products have been transferred.

    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