BEUDAMED
    FDA Enforcement Class II Terminated

    AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.

    Recall: Z-2439-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2439-2018
    Event ID
    80301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Opgen Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    May 14, 2018
    Classification Date
    July 13, 2018
    Termination Date
    April 8, 2019
    Address
    708 Quince Orchard Rd Ste 220, Gaithersburg, MD, 20878-1764, United States

    Description

    AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included as a component of the QFFIXBC1-25. The slides will provide non-fluorescent, wettable surface with dimensions appropriate for testing samples with QuickFISH BC culture identification kits.

    Reason

    Possible diminished performance prior to its established expiration date.

    Code Info

    Lot Number: 17306401 Expiration Date: November 2018 (2018-11)

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AZ, CA, IL, TX & WA; and countries of: Italy & Denmark.

    Quantity

    800 total (32 kits/25 slides per kit)