Events

Recall of COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use

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
    26040
  • Event Risk Class
    Class 3
  • Event Number
    Z-0805-03
  • Event Initiated Date
    2003-03-28
  • Event Date Posted
    2003-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26918
  • 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
    Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
  • Reason
    Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
  • Action
    The firm sent notification letter and modified operating instructions by mail on March 28, 2003.

Device

COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
  • Model / Serial
    All existing versions of the software.   Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA and Canada
  • Product Description
    COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 South Kraemer Blvd W 337, Brea CA 92822
  • Source
    USFDA