BEUDAMED
    FDA Recall Terminated

    Sample Management System software for in vitro diagnostic testing Product # 030102-03

    Recall: Z-0545-2007 · Initiated January 15, 2007

    Recall

    Recall Number
    Z-0545-2007
    Event Number
    37160
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    1000122204
    Product Code
    CDD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 15, 2007
    Posted
    March 1, 2007
    Terminated
    January 18, 2008
    Address
    62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715

    Description

    Sample Management System software for in vitro diagnostic testing Product # 030102-03

    Reason

    Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.

    Action

    A recall communication was sent on 1/15/2007 to all customers by fax.

    Distribution

    Worldwide, including USA, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and United Kingdom.

    Quantity

    87 units