Events

Recall of AQUIOS CL Flow Cytometer Software

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
    76961
  • Event Risk Class
    Class 2
  • Event Number
    Z-2035-2017
  • Event Initiated Date
    2017-04-03
  • Event Date Posted
    2017-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154696
  • 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
    Flow cytometric reagents and accessories. - Product Code OYE
  • Reason
    Beckman coulter has confirmed that the export feature located in the results area of the aquios system software is not correctly exporting tetra combo crd files.
  • Action
    An Urgent Medical Device Recall letter was sent on 4/3/17 to inform customers that area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. The letter informs the customers of the impact, action, and resolution. 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 website, http://www.beckmancoulter.com/customersupport/support, Via phone, call 1-800-369-0333 in the US. Customers outside the US are instructed to contact their local Beckman Coulter Representative.

Device

AQUIOS CL Flow Cytometer Software
  • Model / Serial
    All
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide - US Nationwide in the countries of: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Kingdom and Zambia
  • Product Description
    AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 || Product Usage: || The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).
  • 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