Events

Recall of Device Recall Beckman Coulter UniCel Dxl 800 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
    34581
  • Event Risk Class
    Class 2
  • Event Number
    Z-0583-06
  • Event Initiated Date
    2006-02-06
  • Event Date Posted
    2006-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44133
  • 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
    The unicel dxl 800 access immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances).
  • Action
    A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)

Device

Device Recall Beckman Coulter UniCel Dxl 800 Access Immunoassay System
  • Model / Serial
    Part Numbers: 386162 (software) 973100 (Instrument),  Software Versions 2.2.1 and earlier.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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