Events

Recall of Synchron Systems LX20/ UniCel DxC ISE Reference Reagent

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
    65655
  • Event Risk Class
    Class 2
  • Event Number
    Z-1951-2013
  • Event Initiated Date
    2010-09-22
  • Event Date Posted
    2013-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119820
  • 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
    Electrode, ion specific, potassium - Product Code CEM
  • Reason
    Beckman coulter is recalling the synchron systems lx20/unicel dxc ise reference reagent because it has a potassium (k) response near the instrument calibration flag limits and may exceed the limits on some instruments.
  • Action
    Beckman Coulter Inc sent an Urgent Product Corrective Action (PCA) letter dated September 22, 2010 to all affected customers. Customers were notified of the the problems identified and the actions to be completed. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and in Canada.

Device

Synchron Systems LX20/ UniCel DxC ISE Reference Reagent
  • Model / Serial
    Lot No. T006042
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom
  • Product Description
    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. || Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA