BEUDAMED
    FDA Recall Terminated

    BS-200 Chemistry Analyzer Designed for clinical laboratory use.

    Recall: Z-0977-2013 · Initiated November 28, 2012

    Recall

    Recall Number
    Z-0977-2013
    Event Number
    64112
    Firm
    Mindray DS USA, Inc. d.b.a. Mindray North America
    FEI Number
    2221819
    Product Code
    CFR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 28, 2012
    Posted
    March 22, 2013
    Terminated
    June 12, 2013
    Address
    800 MacArthur Blvd., Mahwah, NJ, 07430

    Description

    BS-200 Chemistry Analyzer Designed for clinical laboratory use.

    Reason

    An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.

    Action

    Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.

    Distribution

    Distributed in the states of NC and TX.

    Quantity

    3 units