Events

Recall of Device Recall Beckman Coulter UniCel DxI 800

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
    56408
  • Event Risk Class
    Class 2
  • Event Number
    Z-2685-2011
  • Event Initiated Date
    2010-07-06
  • Event Date Posted
    2011-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93643
  • 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
    Test results may have incorrect ranges. if a default sample type setting on the tests screen is changed while running unicel dxi system software version 4.3, the new setting is not saved to the system database. the changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. if the default sample type i.
  • Action
    Beckman Coulter forwarded on 7/6/10 a Product Corrective Action letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the UniCel Dxl 600 and Dxl 800 Access Immunoassay systems. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: A revised version of UniCel DxI System Software that corrects this issue is currently in development. Until the new software version is available, Beckman Coulter has provided an alternate method for changing the default sample type setting. See the appendix included with this letter for additional information. Refer to the attached Questions and Answers document for additional details and instructions, and to determine if their laboratory is running UniCel DxI Sytem Software version 4.3. Customers may wish to confirm that proper ranges and units of measure are being reported for any Access assays with sample type settings that were changed while running software version 4.3. Customers were asked to share this information with their laboratory staff, and retain the notification as part of their laboratory Quality Ststem documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that consignees received the notification. If they need assistance or have any questions regarding this notification, customers were told to contact Technical Support at 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.

Device

Device Recall Beckman Coulter UniCel DxI 800
  • Model / Serial
    Part Numbers: A71456, 973100, A25288, A25285 with Unicel DXI system software version 4.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in the US and to Canada
  • Product Description
    Beckman Coulter UniCel DxI 800 Access Immunoassay System with Unicel DXI system software version 4.3
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA