BEUDAMED
    FDA Recall Terminated

    Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.)

    Recall: Z-0718-2008 · Initiated June 25, 2007

    Recall

    Recall Number
    Z-0718-2008
    Event Number
    38335
    Firm
    Hamilton Co
    FEI Number
    2915796
    Product Code
    JTC
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 25, 2007
    Posted
    February 8, 2008
    Terminated
    April 15, 2008
    Address
    4970 Energy Way, Reno, NV, 89502-4123

    Description

    Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400. Hamilton Company, Reno, NV 89520 (Accessory on the Microlab STAR series instruments.)

    Reason

    Incorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the results of testing. The instrument will discover the error and post an error notice.

    Action

    The firm sent an Urgent: Product Recall letter to consignees on June 25, 2007. The firm also issued an alert via their User news distribution. They instructed consignees to examine their stock and return any affected carriers. A fax back form was supplied with the notification. The firm will be providing replacements.

    Distribution

    Worldwide Distribution --- USA including states of OH, CA, NJ, NC, and countries of Japan, France, Switzerland, Spain, Italy, Germany, and the UK.

    Quantity

    179 units distributed.