Events

Recall of Device Recall LH 700

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
    25630
  • Event Risk Class
    Class 3
  • Event Number
    Z-0669-03
  • Event Initiated Date
    2002-12-27
  • Event Date Posted
    2003-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26177
  • 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
    Incorrect hemoglobin result can be reported with software version 2a and higher.
  • Action
    Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.

Device

Device Recall LH 700
  • Model / Serial
    All instruments with version 2A or higher.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    LH 700 Series Hematology Analyzers. || Part numbers 66056032, 6605633, 6605645
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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