BEUDAMED
    FDA Recall Terminated

    LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

    Recall: Z-0914-05 · Initiated May 19, 2005

    Recall

    Recall Number
    Z-0914-05
    Event Number
    32066
    Firm
    Esa Biosciences, Inc.
    FEI Number
    1218996
    Product Code
    DOF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 19, 2005
    Posted
    June 21, 2005
    Terminated
    November 21, 2005
    Address
    22 Alpha Rd, Chelmsford, MA, 01824-4123

    Description

    LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233

    Reason

    Lead test results may be reported lower than the actual value

    Action

    ESA is notifying beginning 5/19/05 to Distributors and End Users by letter sent First Class Mail. Additionally Distributors may be notified by phone to ensure receipt of letter. Customers will be asked to return product to ESA for destruction. A fax back form is included with the notification letter. Customers will fax back the number of Test Kits that they require replacement for. ESA will ship replacement kits and include a prepaid return shipping label for the customer to return defective kits to ESA.

    Distribution

    United States Foreign: Mexico, Canada, Indonesia, Palestine, Kingdom of Saudi Arabia, Columbia, Switzerland, Romania, West Indies, Italy, Japan, Turkey, United Kingdom, Phillipines, Singapore, Jamaica, Uraguay, South Korea, Peru, Tanzia, South Africa, Quatar, Croatia, Zambia, China, Germany

    Quantity

    14,760 test kits