Events

Recall of Access 2 Immunoassay System

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
    66397
  • Event Risk Class
    Class 2
  • Event Number
    Z-0291-2014
  • Event Initiated Date
    2013-09-12
  • Event Date Posted
    2013-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122247
  • 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
    Beckman coulter is recalling the access 2 immunoassay system because they determined that the fuses in the system may be of the wrong amperage.
  • Action
    A phone call was made on 9/12/13 to customer who received the Access 2 System. The phone script explains the problem identified of a possible wrong fuse and may result in failure of the fuse to operate properly. Customer was instructed that their Field Service Engineer, will call them back the following week to check on their system and replace the fuses if necessary. If you have any questions concerning this information, please call 952-393-8546.

Device

Access 2 Immunoassay System
  • Model / Serial
    Serial Numbers:  508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.
  • Product Description
    Access 2 Immunoassay System, Part Number: 81600N || The Access 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