Events

Recall of COULTER GENS 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
    44916
  • Event Risk Class
    Class 2
  • Event Number
    Z-0315-2008
  • Event Initiated Date
    2007-04-18
  • Event Date Posted
    2007-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64532
  • 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
    Beckman Coulter, Brea, CA. (Hematology analyzer) - Product Code GKL
  • Reason
    Patient mis-identification can occur: 1)- when a positive identifier (sample id or cassette/position) is manually edited to a positive identifier that is already in the to do list. the workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- when manually entering a patient id, if a blank space is entered between th.
  • Action
    Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.

Device

COULTER GENS System
  • Model / Serial
    Part Number 6605381. All software versions
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide: USA and Canada
  • Product Description
    COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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