Events

Recall of Synchron LX Systems Primary Tube Sample Template || (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). || Part Number: 967178

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
    26722
  • Event Risk Class
    Class 3
  • Event Number
    Z-1077-03
  • Event Initiated Date
    2003-06-19
  • Event Date Posted
    2003-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28262
  • 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
  • Reason
    Dead volume on sight gauge for the synchron lx 20 and lx 20 pro systems not stated, which may result in instrument error.
  • Action
    A revised template with a recall letter was sent to customers with a response request on 19 June 2003.

Device

Synchron LX Systems Primary Tube Sample Template || (a piece of ''labeling'' for use with the Syn...
  • Model / Serial
    No range of serial numbers apply.
  • Distribution
    USA and Canada.
  • Product Description
    Synchron LX Systems Primary Tube Sample Template || (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). || Part Number: 967178
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 South Kraemer Blvd W 337, Brea CA 92822
  • Source
    USFDA