BEUDAMED
    FDA Enforcement Class II Ongoing

    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

    Recall: Z-0704-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0704-2024
    Event ID
    93526
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    November 27, 2023
    Classification Date
    January 10, 2024
    Address
    515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States

    Description

    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

    Reason

    A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

    Code Info

    UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024

    Distribution

    US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD

    Quantity

    57 Kits