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
    78613
  • Event Risk Class
    Class 3
  • Event Number
    Z-0309-2018
  • Event Initiated Date
    2017-11-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159895
  • 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
    Potential for minor skin burn if the tool contacts the reagent storage interface board (b79917) when performing a pipettor alignment.
  • Action
    An Urgent Medical Device Recall letter, dated November 6, 2017, were sent to the affected customers via mail. The letter identifies the affected device, the reason for recall, impact, and actions to be taken. The firm states that customers may continue to operate their system normally. Customers are instructed to contact Technical Support if a device on the Access 2 instrument needs alignment. The alignment tool is only to be used by the Beckman Coulter service personnel and Beckman Coulter trained biomedical engineers. A Beckman Coulter service rep will contact customers to schedule a service visit. Customers are to share this information with their staff and retain a copy of the letter. Customers are to respond via one of the ways identified. Beckman Coulter should be contacted with any questions regarding the notice.

Device

Device Recall Access 2 Immunoassay System
  • Model / Serial
    Serial/Lot Numbers: 507114, 503299 and 508111
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
  • Product Description
    Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. || 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