Events

Recall of Device Recall FlowCount Fluorospheres

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
    45918
  • Event Risk Class
    Class 2
  • Event Number
    Z-0525-2008
  • Event Initiated Date
    2007-05-21
  • Event Date Posted
    2008-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66482
  • 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
    Differential Cell Counter - Product Code GKZ
  • Reason
    Sporadic absolute count recovery failures with assayed control cell products when using lot number 754801f of the flow-count fluorospheres. additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the evidence of deterioration section of the package insert.
  • Action
    A Product Corrective Action (PCA) letter was mailed on May 21, 2007, to all accounts that have ordered Flow-Count Fluorospheres, Part Number 7547053, Lot # 754801F. The letter advised that Beckman Coulter has confirmed absolute count recovery failures with assayed control cell products. Additionally, internal testing has indicated secondary fluorescent populations slightly above their indicated 20% of the total population as stated in the Evidence of Deterioration section of the Package Insert. The letter requests that users immediately discard any bottles of the product and call for a replacement. If no evidence of deterioration has been observed, the firm states that there should not be any negative impact to the results obtained. A response form is included and should be returned to the firm within 10 days. Questions regarding this recall can be addressed by contacting Beckman Coulter Customer Service at 1-800-526-7694.

Device

Device Recall FlowCount Fluorospheres
  • Model / Serial
    Part Number 7547053, Lot Number 754801F
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada. ***CENTER COMMENTS -- The Center requests that the subject recall not be terminated until CDRH has determined that the firm has identified the root cause and performed an adequate CAPA to address the cause of the problem, i.e., quality control.***
  • Product Description
    Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA