Events

Recall of AQUIOS Lyse Reagent Kit

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
    75503
  • Event Risk Class
    Class 2
  • Event Number
    Z-0648-2017
  • Event Initiated Date
    2016-10-19
  • Event Date Posted
    2016-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150558
  • 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 is recalling the aquios lyse reagent kit because it may lead to an increased generation of notifications and flags when used on the aquios cl when running the aquios tetra application. the issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. depending on the specimen age, a new blood specimen may be required.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated October 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions regarding the notice are instructed to contact our Customer Support Center http://www.beckmancoulter.com/customersupport/support; 1-800-369-0333 in the US and Canada; outside the US and Canada contact local Beckman Coulter Representative.

Device

AQUIOS Lyse Reagent Kit
  • Model / Serial
    6040014K 6040015K
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Italy, Malaysia, Netherlands, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Zambia
  • Product Description
    AQUIOS Lyse Reagent Kit, Catalog No. B23538 || Product Usage: || AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white 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