Recall of Device Recall UniCel Dxl 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
    36225
  • Event Risk Class
    Class 2
  • Event Number
    Z-1518-06
  • Event Initiated Date
    2006-07-28
  • Event Date Posted
    2006-09-23
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Immunoassay system - Product Code JJE
  • Reason
    The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. this may lead to incorrect assay results.
  • Action
    A Product Corrective Action (PCA) letter was sent on July 28, 2006 to all Dxl customers to inform them that due to a recent change in packaging it is possible that the neck of the wash buffer cube can be extended higher than intended. This condition can cause the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. If they are running System software version 2.2.2 (distributed beginning March 2006) and greater it will detect the premature out-of-buffer state, thus preventing the potential for erroneous results. The letter also informed the customers that if they run system software version 2.2.1 or earlier with these wash buffer lot numbers, the premature out-of-buffer state will not be detected immediately, leading to the potential for erroneous results. They were informed that Installation of software version 2.2.2 or greater is mandatory. To ensure immediate upgrade to version 2.2.2, customers are to contact the Clinical Support Center or their local Beckman Coulter representative. After system software version 2.2.2 or greater is installed, the system will detect the out-of-buffer state, stop sample processing, and suppress results. One of the following Event Log messages will be posted: ''Air or excessive restriction has compromised wash buffer delivery'' or ''Air detected in the wash buffer supply line'' To prevent out-of-buffer events users are to complete the enclosed procedure: Calibrating the Wash Buffet Level Sensor. Completing the enclosed procedure before using any of the affected lots of Part Number 8547197 will eliminate unnecessary workflow interruptions. Customers are to share the information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. They are also instructed to complete and return the enclosed response form within 10 days so that the firm can be assured they were notified.

Device

  • Model / Serial
    221208F (exp 6/9/07), 221209F(exp 6/9/07), 221210F (exp 6/10/07), 221211F (exp 6/10/07), 221212F (exp 6/12/07), 221213F (exp 6/12/07), 221214F (exp 6/13/07), 221215F (exp 6/13/07), 221216F (exp 6/14/07), 221217F (exp 6/14/07), 221218F (exp 6/15/07), 221219F (exp 6/15/07), 221220F (exp 6/16/07), 221221F (exp 6/16/07), 221222F (exp 6/17/07), 221223F (exp 6/17/07), 221224F (exp 6/19/07), 221225F (exp 6/19/07), 221226F (exp 6/20/07), 221227F (exp 6/20/07), 221228F (exp 6/21/07), 221229F (exp 6/21/07); All software versions
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- including USA and country of Canada.
  • Product Description
    UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer
  • Manufacturer

Manufacturer

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