Events

Recall of Coulter LH750 Hematology Analyzer. Part Number 6605632.

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
    28873
  • Event Risk Class
    Class 2
  • Event Number
    Z-0905-04
  • Event Initiated Date
    2004-03-31
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32664
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Reason
    If a customer enters a dilution factor for sample b prior to the results from sample a being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the sample a's results once they are received at the workstation.
  • Action
    A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004.

Device

Coulter LH750 Hematology Analyzer. Part Number 6605632.
  • Model / Serial
    Software versions 2A2 and 2B1.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Coulter LH750 Hematology Analyzer. Part Number 6605632.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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