Events

Recall of Device Recall Ultrasonic Transducer Kits

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
    68309
  • Event Risk Class
    Class 2
  • Event Number
    Z-1737-2014
  • Event Initiated Date
    2014-05-14
  • Event Date Posted
    2014-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127315
  • 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 field action because some ultrasonic transducer kits were potentially assembled with incorrect mounting screws.
  • Action
    Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 8, 2014 via first class mail. The letter identified the reason for recall, product information, issue, impact, action, resolution, contact information, and customer response form. Customers are advised to review historical quality control (QC) data and System Check results, and determine whether a review of patient test results is warranted. For questions regarding this letter, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com/customersupport/support, By phone: call 1-800-854-3633 in the United States and Canada, and Outside the United States and Canada, contact your local Beckman Coulter representative

Device

Device Recall Ultrasonic Transducer Kits
  • Model / Serial
    Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640.  Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC  660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
  • Product Description
    Ultrasonic Transducer Kits || For use with the Access Family of Immunoassay Systems*. || *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, || UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i || systems.
  • 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