Events

Recall of Beckman Coulter 1500 Series Hematology Automation System; || Part Number: || 988609 (LH Basic Uint) || 988610 (LH Connection Unit)

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
    32544
  • Event Risk Class
    Class 2
  • Event Number
    Z-1041-05
  • Event Initiated Date
    2005-06-20
  • Event Date Posted
    2005-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40306
  • 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
    Risk of injury to workers due to mechanical or electrical hazards.
  • Action
    Letters were sent advising of the hazard during the week of June 20, 2005 it stated that the units would be upgraded by appointment.

Device

Beckman Coulter 1500 Series Hematology Automation System; || Part Number: || 988609 (LH Basic Ui...
  • Model / Serial
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA and Canada
  • Product Description
    Beckman Coulter 1500 Series Hematology Automation System; || Part Number: || 988609 (LH Basic Uint) || 988610 (LH Connection Unit)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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