Events

Recall of Synchron LX and UniCel DxC Synchron Clinical 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
    55359
  • Event Risk Class
    Class 2
  • Event Number
    Z-2388-2010
  • Event Initiated Date
    2010-04-15
  • Event Date Posted
    2010-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90668
  • 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 CGA
  • Reason
    Unicel dxc and synchron lx instruments produced inaccurate (low) glucm results. false low results could affect or delay diagnosis or treatment.
  • Action
    Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits. Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .

Device

Synchron LX and UniCel DxC Synchron Clinical Systems
  • Model / Serial
    All non-expired lots are affected by the recall.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and Canada
  • Product Description
    GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),
  • 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