Events

Recall of Dimension EXL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dade Behring, 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
    49608
  • Event Risk Class
    Class 2
  • Event Number
    Z-0581-2009
  • Event Date Posted
    2009-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73915
  • 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, free thyroxine - Product Code JJE
  • Reason
    Error messages, "wash aspirator failure" and "wash station unable to recover" are not generated when one or both hm wash probes are totally occluded.
  • Action
    The recalling firm notified consignees by telephone to inform them of the problem. A follow-up letter, "Urgent Field Safety Notice" dated 9/30/08 was issued with information describing the problem, the possible impact of an occluded wash probe on assay results, and emphasizing regular performance of routine wash probe maintenance as detailed in the operator guide to prevent wash probe occlusion. For questions, please contact the Siemens Technical Solution Center at 800-441-9250.

Device

Dimension EXL
  • Model / Serial
    Software versions 8.5.1 and 8.5.1SP3.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.
  • Product Description
    Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. || The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
  • Manufacturer
    Dade Behring, Inc.

Manufacturer

Dade Behring, Inc.
  • Manufacturer Address
    Dade Behring, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA