BEUDAMED
    FDA Recall Terminated

    RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.

    Recall: Z-0828-2010 · Initiated December 17, 2009

    Recall

    Recall Number
    Z-0828-2010
    Event Number
    54184
    Firm
    Gibson Laboratories Inc
    FEI Number
    1050138
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 17, 2009
    Posted
    February 24, 2010
    Terminated
    September 21, 2012
    Address
    1040 Manchester St, Lexington, KY, 40508-2422

    Description

    RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.

    Reason

    Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use.

    Action

    On 12/10/2009 the firm sent letters to their customers notifying them of the problem and instructing them to replace insert with a new one. They were also instructed to complete and return a "Recall Response Form."

    Distribution

    Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.

    Quantity

    15,330 units