BEUDAMED
    FDA Recall 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 · Initiated May 14, 2018

    Recall

    Recall Number
    Z-2439-2018
    Event Number
    80301
    Firm
    Opgen Inc
    FEI Number
    3007065145
    Product Code
    LJG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 14, 2018
    Terminated
    April 8, 2019
    Address
    708 Quince Orchard Rd, Ste 220, Gaithersburg, MD, 20878-1764

    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.

    Action

    On May 9, 2018, OpGen, Inc. notified all affected customers by email. On May 14, 2018, OpGen, Inc. (formerly AdvanDx, Inc.) issued Medical Device Recall notices and acknowledgement forms to their customers via email. Customers were advised to take the following actions: - Inspect stock, quarantine the impacted product and dispose of it in the proper manner. - Complete and return the Acknowledgement of Receipt and Destruction of Materials Form via mail to: OpGen, Inc. Attn: Regulatory Affairs, 708 Quince Orchard Dr., Suite 205, Gaithersburg MD 20878; Fax to: 1 (30) 869-9684 or email to: [email protected]. - Should you encounter any false positive or false negative results in either control well of QuickFISH Slides Lot 17306401, please contact OpGen Technical Support immediately at [email protected]. Customers with questions may contact the firm via telephone 1-866-376-0009 or by e-mail: [email protected].

    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)