Events

Recall of BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM (DONOR SCREENING) - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    114427
  • Event Risk Class
    III
  • Event Initiated Date
    2011-06-02
  • 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
    The content of the pk7300 on-line help file and the pk7300 user's guide are different. change control is in place for hard copy versions of the user's guide and the local hard copy is the primary reference for the operators. there is no assurance that the on-line version of the user's guide has up to date "instructions for use" in all languages.

Device

BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM (DONOR SCREENING) - INSTRUMENT
  • Model / Serial
    Model Catalog: PK7300 (Lot serial: All)
  • Product Description
    BECKMAN COULTER PK7300 AUTOMATED MICROPLATE SYSTEM (DONOR SCREENING) - INSTRUMENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.