BEUDAMED
    FDA Recall Terminated

    Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.

    Recall: Z-0467-2015 · Initiated September 18, 2014

    Recall

    Recall Number
    Z-0467-2015
    Event Number
    69621
    Firm
    Biomerica
    FEI Number
    3007981058
    Product Code
    JKR
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    September 18, 2014
    Posted
    December 16, 2014
    Terminated
    March 28, 2015
    Address
    17571 Von Karman Ave, Irvine, CA, 92614-6207

    Description

    Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.

    Reason

    A potential issue with false high values.

    Action

    An Urgent Field Safety Notice dated 9/18/14 was sent to all their customers who purchased the Calcitonin ELISA Kit. The letter informed the customers of the problems identified and the actions to be taken. Customers were to examine their inventory immediately and quarantine any affected product. Also, customers were asked to notify any customers that the product was further distributed to. Customers with questions were instructed to contact their local Customer Service or Sales Representative regarding the recall notification. Customers were instructed to complete and return the enclosed response form by either fax or email as soon as possible and not later than 10/1/14.

    Distribution

    Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.

    Quantity

    1,062 units