BEUDAMED
    FDA Recall Terminated

    FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

    Recall: Z-1448-2020 · Initiated August 20, 2019

    Recall

    Recall Number
    Z-1448-2020
    Event Number
    84887
    Firm
    Biofire Defense
    FEI Number
    3010770794
    Product Code
    PRD
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 20, 2019
    Posted
    February 18, 2020
    Terminated
    October 30, 2020
    Address
    79 W 4500 S, Ste 14, Salt Lake City, UT, 84107-2649

    Description

    FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only

    Reason

    The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.

    Action

    On 8/20/2019, a "Urgent: Customer Recall Notice" letter was sent to all affected consignees informing them on the recall. In addition to providing information on the recall, the firm asked consignees do the following: 1. BFDf has enclosed a replacement printed copy of the Revision 02 Warrior IFU with this notice. BFDf advises customers to remove and dispose of all incorrect IFUs included in non-expired product from the affected lots listed. BFDf will provide additional replacement copies of the IFU on request. 2. Please complete and return the accompanying Recall Acknowledgement of Receipt Form included with this Notice, using one of the listed methods to confirm your receipt of this notification. 3. If you have any additional questions or concerns, please do not hesitate to contact BFDf Customer Support via email at [email protected] or via telephone at 1-801-262-3592 for product technical support.

    Distribution

    US: UT, MD, GA, CO, OH, TX, OUS: None

    Quantity

    92 kits