Events

Recall of Beckman Coulter

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
    27512
  • Event Risk Class
    Class 2
  • Event Number
    Z-0136-04
  • Event Initiated Date
    2003-10-10
  • Event Date Posted
    2003-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29990
  • 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
    Kit, Dna Detection, Human Papillomavirus - Product Code MAQ
  • Reason
    Labeling error-omission of 'research use only'.
  • Action
    All customers are to be notified with a product correction action letter.

Device

Beckman Coulter
  • Model / Serial
    Lot # 760203k-760208k, 760213k, 760218k
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Coulter DNA Prep Reagents Kit Part 6607055
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92821-6208
  • Source
    USFDA