Events

Recall of Device Recall Siemens Dimension(R) Chemistry Wash (RD701)

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
    65131
  • Event Risk Class
    Class 2
  • Event Number
    Z-0561-2014
  • Event Initiated Date
    2013-05-06
  • Event Date Posted
    2013-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117953
  • 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 (two-site solid phase), ferritin - Product Code JMG
  • Reason
    Siemens healthcare diagnostics received complaints of chemistry wash causing qc and patient sample result shifts on ctn1, ltn1, ft4, tsh, pbnp and lpbn when using chemistry wash lots rd23031, rd23111, rd23241, rd23311, rd23391, and rd23461. these lots shipped between 12/12/2012 and 3/22/2013. internal investigation has confirmed shifts can be encountered in two scenarios: 1 - when an affected l.
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated May 2013 to all affected customers. The letter identified the product and lots, the reason for the field action, the risk to health and the action(s) to be taken. Customers were instructed to discontinue use and discard inventory of the affected product. Siemens will replace any unused inventory of the affected lots at no charge. For questions contact your Siemens Technical Center or your local Siemens technical support representative.

Device

Device Recall Siemens Dimension(R) Chemistry Wash (RD701)
  • Model / Serial
    Lot numbers RD23031, exp 2013-04-29; RD23111, exp 2013-05-07; RD23241, exp 2013-05-19; RD23311, exp 2013-06-04; and RD23461, exp 2013-06-11
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and OUS.
  • Product Description
    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 || Product Usage: Used in the Dimension(R) system with the heterogeneous module
  • 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