BEUDAMED
    FDA Enforcement Class II Terminated

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    Recall: Z-1529-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1529-2018
    Event ID
    79631
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accelerate Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 2, 2018
    Initiation Date
    March 14, 2018
    Classification Date
    April 26, 2018
    Termination Date
    January 17, 2023
    Address
    3950 S Country Club Rd Ste 470, N/A, Tucson, AZ, 85714-2240, United States

    Description

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    Reason

    The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

    Code Info

    Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.

    Distribution

    Distributed to IL, TX, CA, SC, and DE.

    Quantity

    95 kits