Events

Recall of Device Recall Access 2; Immunoassay System Analyzer

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
    66958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-2014
  • Event Initiated Date
    2013-11-26
  • Event Date Posted
    2014-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124322
  • 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 access 2 immunoassay system analyzer and the unicel dxi 600 access may have been manufactured with non-conforming bushings. non-conforming bushings have a remote probability of generating incorrect results.
  • Action
    Beckman Coulter initiated this recall by sending recall notifications to customers. An Urgent Product Correction letter sent to affected customers. The recall letter dated November 22, 2013 informed customer of the recall, products with description and codes, issue, impact, action, resolution, and contact information.

Device

Device Recall Access 2; Immunoassay System Analyzer
  • Model / Serial
    Part Number 81600N. Serial Numbers 508957, 508963, 508964.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
  • Product Description
    Access 2 Immunoassay System Analyzer. || 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