Events

Recall of Device Recall SYNCHRON Rheumatoid Factor (RF) Reagent

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
    61182
  • Event Risk Class
    Class 2
  • Event Number
    Z-1194-2012
  • Event Initiated Date
    2011-06-20
  • Event Date Posted
    2012-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107473
  • 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
    System, test, rheumatoid factor - Product Code DHR
  • Reason
    The recall was initiated because beckman has confirmed that the all in date lots of synchron rheumatoid factor (rf) reagent might generate false positive results or calibration failures.
  • Action
    Beckman Coulter sent an Urgent Field Safety Notice/Product Correction letter dated June 20, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that Beckman Coulter is developing a new RF assay. In the meantime due to current issues related to shelf life and low end sensitivity, Beckman has decided to take the product off the market effective immediately. Beckman will keep the customers updated on their progress and advise when the new assay becomes available. Customers were instructed to complete and return the enclosed Response Form with in 10 days. Customers with questions regarding this notice can contact their local Beckman Sales representative or contact Customer Support Center at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the US and Canada.

Device

Device Recall SYNCHRON Rheumatoid Factor (RF) Reagent
  • Model / Serial
    All in-date lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and worldwide to foreign countries: Australia, Belgium, China, Costa Rica, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macao, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, and the United Kingdom.
  • Product Description
    SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 || A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues.
  • 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