Events

Recall of COULTER DxH 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
    71045
  • Event Risk Class
    Class 2
  • Event Number
    Z-1616-2015
  • Event Initiated Date
    2015-04-13
  • Event Date Posted
    2015-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135907
  • 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 has received an increased number of complaints related to hemoglobin (hgb) on unicel dxh 800 and dxh 600 coulter cellular analysis systems. the use of the dxh diluent lots listed in the recall notice may eventually result in a compromised hgb chamber.
  • Action
    An Urgent Medical Device Recall letter dated 4/13/15 was sent to customers who purchased the Coulter DxH Diluent. The letter informs customers that Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Center via http://www.beckmancoulter.com/customersupport/support or call (800) 526-7694 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

Device

COULTER DxH Diluent
  • Model / Serial
    Lot No. 3099980 - 3512190, expiration dates: 17 April 2015 - 26 August 2016.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Argentina; Brazil; Brunei Darussalam; Canada; Chile; Colombia; Hong Kong; India; Lebanon; Macao; Mexico; Panama; Philippines; Qatar; Singapore; Taiwan; Thailand; Trinidad and Tobago; United States, including Puerto Rico; and Uruguay.
  • Product Description
    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. || For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
  • 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