Events

Recall of Device Recall 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
    76688
  • Event Risk Class
    Class 2
  • Event Number
    Z-1709-2017
  • Event Initiated Date
    2017-03-07
  • Event Date Posted
    2017-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153845
  • 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 family of immunoassay systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. the position errors cause the instrument to stop running and cancel tests that are in process.
  • Action
    An Urgent Medical Device Recall letter was sent on 3/7/17 to inform customers that Beckman Coulter has determined through internal investigation that a circuit board that controls motor functions in the instrument systems listed above can affect device positioning on the pipettor and incubator belt while the instrument is running. Customers are informed of the impact, action to be taken, and the resolution. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: ¿ From our website: http://www.beckmancoulter.com ¿ By phone: call 1-800-854-3633 in the United States and Canada. ¿ Outside the United States and Canada, contact your local Beckman Coulter representative.

Device

Device Recall Access 2 Immunoassay System
  • Model / Serial
    Serial No. 511527 - 511678; 511681 - 512212
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
  • Product Description
    Access 2 Immunoassay Systems, Part No. 81600N || Product Usage: || The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices 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