Events

Recall of OLYMPUS PK7200 AUTOMATED MICROPLATE SYSTEM - MICRO PLATE READER

According to Health Canada (via FOI), this recall involved a device in Canada 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
    109925
  • Event Risk Class
    II
  • Event Initiated Date
    2007-01-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Unidentified software error that affects datastream transmitted from the pk7200 analyzer to the facility's laboratory information systems (lis).

Device

OLYMPUS PK7200 AUTOMATED MICROPLATE SYSTEM - MICRO PLATE READER
  • Model / Serial
    Model Catalog: PK7200 (Lot serial: all serial numbers)
  • Product Description
    PK7200 microplate system (software)
  • Manufacturer
    BECKMAN COULTER INC.

Manufacturer

BECKMAN COULTER INC.