Events

Recall of Device Recall Siemens Dimension(R) IRON Calibrator (DC85)

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

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
    64081
  • Event Risk Class
    Class 3
  • Event Number
    Z-0745-2013
  • Event Initiated Date
    2012-12-20
  • Event Date Posted
    2013-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115333
  • 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
    Calibrator, primary - Product Code JIS
  • Reason
    Siemens healthcare diagnostics has received complaints of iron calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using iron calibrator lots 2dn060 and 2fn063. lots 2gn068 and 2jn074 may also be impacted but no complaints have been received.
  • Action
    Siemens sent a "CUSTOMER NOTIFICATION" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Siemens Technical Solutions Center at 1-800-441-9250 or your local Siemens Healthcare Diagnostics representative for assistance with this issue.

Device

Device Recall Siemens Dimension(R) IRON Calibrator (DC85)
  • Model / Serial
    Siemens material number 10445010 -- and lot numbers 2DN060, exp 2013-10-01; 2FN063, exp 2013-12-01; 2GN068, exp 2014-01-01; and 2JN073, exp 2014-03-01.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. || The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA