BEUDAMED
    FDA Recall 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 · Initiated March 17, 2015

    Recall

    Recall Number
    Z-1535-2015
    Event Number
    70823
    Firm
    Biocare Medical, LLC
    FEI Number
    3004140393
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 17, 2015
    Posted
    April 27, 2015
    Terminated
    June 15, 2015
    Address
    4040 Pike Ln, Concord, CA, 94520-1227

    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.

    Action

    Biocare sent a Medical Device Notification letters dated March 17, 2015 to all affected sites. The letters identify the affected product, problem, actions to be taken and the fact that it affects all identified lots shipped between 02/13/13 and / 01/28/15. The letters instructed customers to immediately discontinue further use of the recalled lots, dispose of them according to state and local regulations and complete the response form and returned by April 7, 2015. Credit will be issued upon receipt of the response form.

    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