Events

Recall of Access Immunoassay Systems

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
    58719
  • Event Risk Class
    Class 2
  • Event Number
    Z-3126-2011
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2012-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100311
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The recall was initiated because certain access immunoassays can produce inaccurate results when performed within the published unicel dxi immunoassay systems* room temperature operating specification of 18 degrees c to 32 degrees c (64.4 degrees f to 89.6 degrees f). an increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i.
  • Action
    Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE" letter dated April 18, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter includes information on the new room temperature operating range for all UniCel DxI Immunoassay Systems and Access Immunoassay Systems during system operation. Customers were instructed to review their historical room temperature records to determine if their Access Immunoassay System and UniCel DxI Immunoassay System were operating outside the revised temperature range. An attached Response Form was included for customers to complete and return. Please contact Beckman Coulter Customer Support Center for questions regarding this notice at 1-800-854-3633.

Device

Access Immunoassay Systems
  • Model / Serial
    All Serial Numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and Puerto Rico and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayette, Mexico, Morocco, Nambia, Netherlands, New Zealand, Norway, Philippines, Poland,, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela and Vietnam.
  • Product Description
    Access Immunoassay Systems Part Number: 81600 || Access 2 Immunoassay Systems Part Number: 81600N || Access Immunoassay Systems LXi 725 Part Number: 386200 || Subsequent Product Codes: JGS || The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • 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