Events

Recall of UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System

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
    48186
  • Event Risk Class
    Class 2
  • Event Number
    Z-2387-2008
  • Event Initiated Date
    2008-04-03
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72500
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the access and access 2 immunoassay systems. premature failure of the waste pump tubing may negatively affect precision.
  • Action
    A Product Corrective Action (PCA) letter with attached Fax-Back Customer Response form was mailed on April 16, 2008 via US Postal mail to all affected customers with Access and Access 2 Immunoassay Systems, Synchron LXi 725 Systems and UniCel DxC 600i Systems. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump Mfg. No. 01-00772205 with a SN higher than 2234980. A toll free Customer Technical Support telephone was included in the letter. After further investigation by the firm, an Updated PCA letter with attached Fax-Back Customer Response form was mailed on June 30, 2008 via US Postal mail to include all customers with the following products: UniCel Dxl 800 and DxC 880i Systems with pump manufacturing number (Mfg.) of 01-010341-1 and serial number (SN) 22454201 and above, and UniCel Dxl 600 Systems with a pump Mfg. No. A24468 and SN of 22965501. Customers were informed about the issue and asked to inspect for leaking or damaged tubing on all peristatic pump SN referenced. If you have questions, contact Customer Technical Support at 1-800-854-3633.

Device

UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System
  • Model / Serial
    Peristaltic Pumps with Serial Numbers of 22454201 and above
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, and in Canada
  • Product Description
    UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA