Events

Recall of Access Immunoassay Systems Reaction Vessels

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
    66521
  • Event Risk Class
    Class 2
  • Event Number
    Z-0519-2014
  • Event Initiated Date
    2013-10-02
  • Event Date Posted
    2013-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122543
  • 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
    Beckman coulter is initiating a recall for the access immunoassay systems reaction vessels, including the acess/access 2 immunoassay systems, syncron lxi 725 clinical system, and unicel dxc 600i synchron access clinical system because beckman coulter has observed an intermittent increase in access system "wash carousel motion errors" with specific lots of access system reaction vessels (rvs). i.
  • Action
    Beckman Coulter sent an Urgent Product Correction (PCA) letter dated October 1, 2013, along with a customer response form to all affected customers on October 2, 2013. The customer letter informed customers of the recall with the issue, impact, action (If your Access Immunoassay System experiences Wash Carousel Motion Errors that cannot be corrected with normal troubleshooting measures as outlined in the Access 2 Reference Manual section 6.3, contact Beckman Coulter Customer Technical Support. If you do not have Access System RVs with the lot numbers listed above, or if your Access Immunoassay System is not experiencing Wash Carousel Motion Errors, no additional action is required.), resolution, and contact information, website: http://www.beckmancoulter.com. Customers in the United States and Canada with questions were instructed to call 1-800-854-3633, outside the United States and Canada, customers were instructed to contact their local Beckman Coulter representataive. For questions regarding this recall call 714-961-4941.

Device

Access Immunoassay Systems Reaction Vessels
  • Model / Serial
    Part Number 81901, Lot Numbers: 13181168-13341170.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
  • Product Description
    Access Immunoassay Systems Reaction Vessels. || 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.
  • 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