BEUDAMED
    FDA Enforcement Class II 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 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2138-2014
    Event ID
    68774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advandx Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 13, 2014
    Initiation Date
    July 4, 2014
    Classification Date
    August 1, 2014
    Termination Date
    September 30, 2014
    Address
    400 Tradecenter, Ste 6990, Woburn, MA, 01801, United States

    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

    Code Info

    Lot Number: 04914 Exp. Date: 2015-06

    Distribution

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

    Quantity

    10 kits