Events

Recall of GLU 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
    56746
  • Event Risk Class
    Class 2
  • Event Number
    Z-1619-2011
  • Event Initiated Date
    2010-08-10
  • Event Date Posted
    2011-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94438
  • 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
    Glucose oxidase, glucose - Product Code CEM
  • Reason
    The recall was initiated because cartridge glucose (glu) on unicel dxc and synchron lx instruments may give falsely high results for moderately hemolysed samples. the impact: (1) neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population, (2) other hemolysed samples may be similar.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 10, 2010 with an enclosed fax-back Customer Response Form to the customers. The letter provided the customers with an explanation of the problem identified, the impact and an action to be taken. The customers were instructed to run samples using another method/technology and to complete and return the enclosed FAX BACK RESPONSE FORM via fax to (714) 961-4232 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., PO Box 8000, Brea, CA 92822. Firms with questions regarding this Product Corrective Action letter, were instructed to call our Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada http://www.beckmancoulter.com/customersupport/support/default.asp.

Device

GLU Reagent
  • Model / Serial
    All non-expired lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and country: Canada.
  • Product Description
    GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; || SYNCHRON and UniCel Systems and Part Numbers: || Synchron LX20, Part Number: 466200, || Synchron LX20 PRO, Part Number: 476100, || Synchron LXI 725, Part Number: 476501, || UniCel DxC 600, Part Number: A10405, || UniCel 600 PRO, Part Number: A11810, || UniCel DxC 600i, Part Number: A27318, || UniCel DxC 800, Part Number: A11816, || UniCel DxC 800 PRO, Part Number: A11812, || UniCel DxC 880i, Part Number: A59102, || UniCel DxC 660i, Part Number: A64871, || UniCel DxC 680i, Part Number: A64903, || UniCel DxC860i, Part Number: A64935 || (1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA