Events

Recall of In vitro diagnostic reagents for immunochemical analyzers of the ACCESS system series (see Annex on 2 sheets)

According to Federal Service for Surveillance in Healthcare, this recall involved a device in Russian Federation 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
    01И-1881/18, ФСЗ 2010/08527
  • Event Number
    01И-1212/18
  • Date
    2018-08-03
  • Event Date Posted
    2018-08-07
  • Event Country
    Russian Federation
  • Event Source
    FSSH
  • Event Source URL
    http://www.roszdravnadzor.ru/services/unreg
  • Notes / Alerts
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Russia.
  • Extra notes in the data
    Manufacturer Recall

Device

In vitro diagnostic reagents for immunochemical analyzers of the ACCESS system series (see Annex ...

Manufacturer

Beckman Coulter, Inc.