BEUDAMED
    FDA Enforcement Class II Terminated

    CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

    Recall: Z-1535-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1535-2015
    Event ID
    70823
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocare Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    March 17, 2015
    Classification Date
    April 27, 2015
    Termination Date
    June 15, 2015
    Address
    4040 Pike Ln, Concord, CA, 94520-1227, United States

    Description

    CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

    Reason

    A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

    Code Info

    Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.

    Distribution

    Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.

    Quantity

    44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314