Events

Recall of Device Recall COULTER ISOTON 4 Diluent

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
    71835
  • Event Risk Class
    Class 2
  • Event Number
    Z-2481-2015
  • Event Initiated Date
    2015-07-22
  • Event Date Posted
    2015-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139181
  • 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
    Diluent, blood cell - Product Code GIF
  • Reason
    Beckman coulter is recalling the lh 750 and lh780 hematology systems because the use of the diluent lots may eventually result in a compromised hgb cuvette.
  • Action
    An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of the US and Canada, are instructed to contact their local Beckman Coulter Representative.

Device

Device Recall COULTER ISOTON 4 Diluent
  • Model / Serial
    Lot Numbers: 18203F-18206F.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago.
  • Product Description
    COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA