BEUDAMED
    FDA Recall 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 · Initiated March 14, 2018

    Recall

    Recall Number
    Z-1529-2018
    Event Number
    79631
    Firm
    Accelerate Diagnostics Inc
    FEI Number
    3010671651
    Product Code
    PRH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 14, 2018
    Terminated
    January 17, 2023
    Address
    3950 S Country Club Rd, Ste 470, Tucson, AZ, 85714-2240

    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).

    Action

    The recalling firm contacted all customers on 3/14/2018 via telephone, and a follow-up e-mail was also sent containing a technical bulletin #TB000079, entitled Product Correction Notice, dated March 14, 2018. The notice identified the affected devices and the reason for the recall. Customers were asked to please discontinue use of and dispose of all remaining kits from the affected lots, and document the disposal by completing the 'Certificate of Kit Disposal.' Replacement kits will be provided.

    Distribution

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

    Quantity

    95 kits