Events

Recall of Device Recall Access Immunoassay 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
    63632
  • Event Risk Class
    Class 2
  • Event Number
    Z-0612-2013
  • Event Initiated Date
    2012-11-01
  • Event Date Posted
    2012-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114387
  • 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
    It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel.
  • Action
    Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 1, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an enclosed Response Form. Contact Technical Support for questions regarding this notice.

Device

Device Recall Access Immunoassay System
  • Model / Serial
    Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    Access Immunoassay System, || Access 2 Immunoassay System, || Synchron LXi 725 Clinical || System, UniCel DxC 600i || Synchron Access Clinical System || Part Numbers: Access  81600; || Access 2  81600N, 386220, A69186, A25656, A12900; || Access 2 (LXi)  A15642; || Access 2 Section, DxC 600i  A25640. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
  • 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