Events

Recall of Device Recall Digital Fluidics PCB

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50849
  • Event Risk Class
    Class 2
  • Event Number
    Z-1399-2009
  • Event Initiated Date
    2009-01-05
  • Event Date Posted
    2009-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77487
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ige, antigen, antiserum, control - Product Code DGC
  • 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.

Device

Device Recall Digital Fluidics PCB
  • Model / Serial
    IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 62 Flanders-Bartley Rd, Flanders NJ 07836-4715
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA