BEUDAMED
    FDA Enforcement Class II Ongoing

    Accelerate PhenoTest BC kit REF 10102018

    Recall: Z-0346-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0346-2023
    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 10102018

    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: 10102018 UDI-DI Code: 00862011000369 Lot Numbers: 5559A 5556A 5555A 5554A 5553A 5551A 5550A 5548A 5546A 5557A 5558A 5560A 5561A 5562A 5563A 5564A 5567A 5568A 5570A 5571A 5572A 5574A 5578A 5579A 5580A 5583A 5577A 5576A 5581A 5582A 5585A 5586A 5587A 5589A 5590A 5591A 5592A 5594A 5595A 5596A 5597A 5598A 5599A 5601A 5602A 5603A 5604A 5607A 5608A 5610A 5611A 5613A 5614A

    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

    7,160 kits