Events

Recall of Device Recall AQUIOS CL Flow Cytometer System

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
    77997
  • Event Risk Class
    Class 2
  • Event Number
    Z-3135-2017
  • Event Initiated Date
    2017-08-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158468
  • 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 identified that an incorrect setting using a proprietary software configuration tool can result in the sample prep probe of the aquios cl drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
  • Action
    The firm, Beckman Coulter, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 16, 2017 to the affected customers via email, mail, and phone during the week of August 21, 2017. The letter described the product, problem and actions to be taken. The customers are instructed to follow instructions provided in the letter and complete and return the Customer Response Form within 10 days via Fax to: (786)-639-7500 /7501 /7502 /7504; mail to: Beckman Coulter, Inc.,- Attn: Regulatory Affairs Mail Code 31-B06; 11800 S.W. 147th Avenue; P O BOX 169015, Miami, FL 33116-9015 or email (if received electronically) at: Regulatory.Notifications@beckmancoulter.com -include in subject field: FA-31696 AQUIOS CL August 2017. If you have any questions regarding this notification, please contact: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 800-369-0333 in the United States and Canada. ¿ By email: LScustomerLetter@Beckman.com ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.

Device

Device Recall AQUIOS CL Flow Cytometer System
  • Model / Serial
    All software versions.; Serial numbers - BA30048, AY20032, BA01007, AZ19046, AZ12030, BA25046, BA05011, AY51072, BA01002, AZ15044, BA30049, BA30050, BA05015, AZ19047, BA18029, AY47071, AZ15038, BA23036, BA23035, AZ23058, AZ20057, AY47063, BA15024, BA15023, AZ45080, BA01010, AZ25070, AZ32071, AZ12033, AZ25065, AZ25068, AY51075, AZ19052, BA15025
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia
  • Product Description
    AQUIOS CL Flow Cytometer System || The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
  • 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