Events

Recall of OLYMPUS PK7200 SYSTEM - ANALYZER CLASS 3

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
    28531
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-14
  • 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
    Beckman coulter has confirmed the presence of deformed well terraces in the pk microplate wells may cause fold over or slip down of positive reaction patterns in the pk7200 and pk7300 automated microplate system.

Device

OLYMPUS PK7200 SYSTEM - ANALYZER CLASS 3
  • Model / Serial
    Model Catalog: PK7200 (Lot serial: P4-93B94B99C); Model Catalog: PK7200 (Lot serial: FOR MICROPLATES:); Model Catalog: PK7200 (Lot serial: P3-91A92A93A95D96D); Model Catalog: PK7300 (Lot serial: FOR MICROPLATES:); Model Catalog: PK7300 (Lot serial: P4-93B94B99C); Model Catalog: PK7300 (Lot serial: P3-91A92A93A95D96D)
  • Product Description
    P3 P4 PLATES FOR THE PK7200 AUTOMATED MICROPLATE SYSTEM-ANALYZER CLASS 3
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.