BEUDAMED
    FDA Enforcement Class II Terminated

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    Recall: Z-2450-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2450-2021
    Event ID
    88450
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gibson Bioscience
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 22, 2021
    Initiation Date
    July 1, 2021
    Classification Date
    September 10, 2021
    Termination Date
    May 2, 2023
    Address
    1040 Manchester St, N/A, Lexington, KY, 40508-2422, United States

    Description

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    Reason

    A lot of KOH 10% was made with Hydrogen Peroxide 3% instead of KOH 10%.

    Code Info

    Lot 21137116, UDI 10634853000633

    Distribution

    US Domestic distribution to NY, KY, ME, NC, NY, CO, CA, and SC.

    Quantity

    11 kits