Events

Recall of DL2000 Data Manager Software, Version 6.4.108

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
    30427
  • Event Risk Class
    Class 3
  • Event Number
    Z-0267-05
  • Event Initiated Date
    2004-11-05
  • Event Date Posted
    2004-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35841
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Reason
    Possibility of reporting an incorrect result occurs due to a software anomally.
  • Action
    Letters were sent to sites on November 5, 2004 to confirm previous telephone conversations with the consignees.

Device

DL2000 Data Manager Software, Version 6.4.108

Manufacturer

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