Events

Recall of Coulter AcT 5diff Autoloader (AL) Hematology Analyzer

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
    28957
  • Event Risk Class
    Class 2
  • Event Number
    Z-0987-04
  • Event Initiated Date
    2004-04-20
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32870
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Reason
    Software anomaly causes sample results to be not credible, reported as '0' or left blank. the next sample will also be incorrectly reported for the same parameter.
  • Action
    Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.

Device

Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
  • Model / Serial
    All software versions (1.00 & 1.20)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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