Events

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
    Recall
  • Event ID
    71022
  • Event Risk Class
    Class 2
  • Event Number
    Z-1658-2015
  • Event Initiated Date
    2015-03-05
  • Event Date Posted
    2015-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135854
  • 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.

Device

Device Recall Siemens IMMULITE 2000 and IMMULITE 2000XPi
  • Model / Serial
    (Water Bottle) - Product Code #10380062; Catalog #10291586
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Water bottles, Catalog#10380062, #10291586. || 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
    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