Events

Recall of Pre-Transfusion Blood Testing System PK7300 Automated Microplate System. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2017-RN-00798-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00798-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Beckman coulter has confirmed that, during sample processing under certain conditions, the pk7300 does not always generate a reagent dispensing pressure error when the reagent vial becomes empty and no reagent is dispensed. sample processing will continue after a vial is empty only when the reagent alarm volume, limit volume and associated mode shift alarm have not been set.False negative test results with blood grouping reagents may occur. results will not be generated for tests using cellular or particle reagents. wells without cellular or particle reagents will be flagged as empty (.E flags).
  • Action
    Beckman Coulter is requesting that customers verify that all of the following are set on all PK7300 analysers in their laboratory: 1. Alarm Volume and Limit Volume in the Common Test Parameter – Name (Reagent tab) menu. 2. Either “To Pause” or “To Measure 2” is selected for “at Short Reagent Volume Alarm” on the Mode Shift tab in the System – System Menu. If the parameters described above have not been set on all PK7300s in your laboratory, please follow the instructions in the PK7300 User’s Guide and the information in the customer letter to set them. When reagent vials are placed in the reagent tray, make sure that each vial is fully seated to the bottom of the tray.

Device

Pre-Transfusion Blood Testing System PK7300 Automated Microplate System. An in vitro diagnostic m...
  • Model / Serial
    Pre-Transfusion Blood Testing System PK7300 Automated Microplate System. An in vitro diagnostic medical device (IVD)ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd