BEUDAMED
    FDA Enforcement Class II Terminated

    BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

    Recall: Z-1903-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1903-2021
    Event ID
    87934
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 30, 2021
    Initiation Date
    May 10, 2021
    Classification Date
    June 21, 2021
    Termination Date
    December 15, 2022
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338

    Reason

    Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.

    Code Info

    Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338

    Distribution

    US nationwide distribution

    Quantity

    870 kits