BEUDAMED
    FDA Enforcement Class II Terminated

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    Recall: Z-1133-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1133-2019
    Event ID
    82354
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioFire Diagnostics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 7, 2019
    Classification Date
    April 12, 2019
    Termination Date
    August 24, 2022
    Address
    515 S Colorow Dr, N/A, Salt Lake City, UT, 84108-1248, United States

    Description

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    Reason

    Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.

    Code Info

    All lots of BCID Panels, when used with the following blood culture bottles, Part Number/Lot Numbers:410851/4052663, 4052639, 4052640, 4052599, 4052598, 4052547, 4052546, 4052471, 4052472, 4052799, 4052800, 4052815, 4052816; 410852/4052871, 4052872, 4052459, 4052458, 4052565, 4052564, 4052705, 4052704, 4052735, 4052617, 405261; 410853/4052717, 4052718, 4052503, 4052504

    Distribution

    MA, NH, VT, CT, NJ, NY, PA, DE, DC, VA, MD, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, AK, BM

    Quantity

    20350