Events

Recall of Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    27432
  • Event Risk Class
    Class 2
  • Event Number
    Z-0096-04
  • Event Initiated Date
    2003-09-18
  • Event Date Posted
    2003-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29866
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Reason
    Sample wheel may home to the wrong position.
  • Action
    Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone.

Device

Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 P...
  • Model / Serial
    All those with version 4.0 operating software.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 South Kraemer Blvd, Brea CA 92821
  • Source
    USFDA