BEUDAMED
    FDA Recall Terminated

    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.

    Recall: Z-1399-2009 · Initiated January 5, 2009

    Recall

    Recall Number
    Z-1399-2009
    Event Number
    50849
    Firm
    Siemens Medical Solutions Diagnostics
    FEI Number
    1000122204
    Product Code
    DGC
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 5, 2009
    Posted
    May 26, 2009
    Terminated
    April 19, 2010
    Address
    62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715

    Description

    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.

    Reason

    Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

    Action

    Siemens Healthcare Diagnostics Inc. issued an "Urgent: Device Recall" notice dated January 2009 mailed to all direct customers of the affected product. The letter described the problem, provided "work-around" instructions and also provided a Recall Response Form to be returned to the firm via fax. For further information, please contact your local Siemens Healthcare support representative or Siemens Healthcare Diagnostics Inc. directly at 1-973-927-2828.

    Distribution

    Worldwide Distribution to states including MA, NY, PA, MD, GA, FL, OH, IN, MI, IL, MO, LA, UT, AZ and CA and countries of Canada, Czech Republic, Germany, Poland, Hungary, Belgium, Russia, Republic of South Africa, Greece, Israel, Turkey, Spain, Portugal, Denmark, France, Great Britain, India, China, South Korea and Mexico.

    Quantity

    295 Digital Fludics PCB (88 IMMULITE 2000 and 2500 and 207 as spare parts).