Events

Recall of Device Recall IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare 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
    67210
  • Event Risk Class
    Class 2
  • Event Number
    Z-1518-2014
  • Event Initiated Date
    2013-12-20
  • Event Date Posted
    2014-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126542
  • 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
    Radioimmunoassay, immunoglobulins (d, e) - Product Code JHR
  • Reason
    Siemens confirmed an overall average positive bias of 23% against the who 2nd irp 75/502 with the immulite systems total ige assays.
  • Action
    Urgent Medical Device Correction Letters (dated 12/20/13) and effectiveness check response forms were sent to customers on 12/20/13 via FedEx to inform them of the issue. Customers were requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions.

Device

Device Recall IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE
  • Model / Serial
    Lots 260 through 275
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. || For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of Total Immunoglobulin type E (IgE) in serum.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA