BEUDAMED
    FDA Enforcement Class II Ongoing

    Accelerate PhenoTest BC kit REF 10101018

    Recall: Z-0345-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0345-2023
    Event ID
    91075
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Accelerate Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    December 7, 2022
    Initiation Date
    October 17, 2022
    Classification Date
    November 30, 2022
    Address
    3950 S Country Club Rd Ste 470, Tucson, AZ, 85714-2240, United States

    Description

    Accelerate PhenoTest BC kit REF 10101018

    Reason

    Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

    Code Info

    Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A

    Distribution

    U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates

    Quantity

    200 kits