Events

Recall of Device Recall IMMAGE Immunochemistry Systems 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
    59016
  • Event Risk Class
    Class 2
  • Event Number
    Z-2887-2011
  • Event Initiated Date
    2011-05-31
  • Event Date Posted
    2011-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100830
  • 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 the listed lots of rheumatoid factor (rf) reagent might produce false positive results. a false positive result might lead to additional unnecessary testing.
  • Action
    Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE/PRODUCT CORRECTION" letter dated May 31, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products. Customers were asked to complete and return an attached FAX BACK Response Form to 714-961-4234. Replacement products may be obtained by calling Order Assistance at 800-526-3821 in the United States, (800) 463-7828 in Canada or contacting your local Beckman Coulter representative. For any questions regarding this notice, contact the Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the United States and Canada; or contact your local sales representative.

Device

Device Recall IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent
  • Model / Serial
    Lot Number: M908398 & M911529
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Macao, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
  • Product Description
    IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. || Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92822-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA