Recall of Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both immulite 2000 and immulite 2000xpi water bottles and liquid waste bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
  • Action
    Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.


  • Model / Serial
    Liquid Waste Bottle Kit - Product Code/Catalog #10386287
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution.
  • Product Description
    Liquid Waste Bottle Kit, Catalog#10386287. || The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
  • Manufacturer


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