BEUDAMED
    FDA Enforcement Class II Terminated

    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

    Recall: Z-2245-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2245-2021
    Event ID
    88410
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    July 20, 2021
    Classification Date
    August 11, 2021
    Termination Date
    December 16, 2022
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127

    Reason

    Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.

    Code Info

    Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003

    Distribution

    U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None

    Quantity

    29 kits