BEUDAMED
    FDA Recall Terminated

    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)

    Recall: Z-2138-2014 · Initiated July 4, 2014

    Recall

    Recall Number
    Z-2138-2014
    Event Number
    68774
    Firm
    Advandx Inc
    FEI Number
    3004080598
    Product Code
    NXX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 4, 2014
    Posted
    August 1, 2014
    Terminated
    September 30, 2014
    Address
    400 Tradecenter, Ste 6990, Woburn, MA, 01801

    Description

    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)

    Reason

    Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

    Action

    AdvanDx notified customers by e-mail on July 4, 2014 of the problem and advised to discontinue use of the QuickFISH Fixation Kits with Lot#04914. Replacement kits were immediately shipped to all of the affected customers. Questions contact local AdvanDx representative or Technical Support 1-866-376-0009, fax 1-781-376-0111 or e-mail: [email protected]. An acknowledgement of Receipt and Destruction of Materials requested to be completed.

    Distribution

    Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.

    Quantity

    10 kits