Events

Recall of Device Recall StreamLab Analytical Workcell

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
    30518
  • Event Risk Class
    Class 2
  • Event Number
    Z-0373-05
  • Event Initiated Date
    2004-11-12
  • Event Date Posted
    2004-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36048
  • 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
    Software can sample the incorrect specimen from the streamlab to the dimension rxl or rxl max systems.
  • Action
    The recalling firm issued letters dated 11/12/04 to their customers informing them of the problem. The letter also states that a sales representative will contact them to make arrangements for an upgrade.

Device

Device Recall StreamLab Analytical Workcell
  • Model / Serial
    Software version 3.5
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals in IL, MD, NJ, OH, and VA. The product was also shipped to Italy, Spain, and Portugal.
  • Product Description
    StreamLab Analytical Workcell. General Purpose Laboratory Device.
  • Manufacturer
    Dade Behring , Inc.

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., Rte 896, Glasgow Business Community, Newark DE 19702
  • Source
    USFDA