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

Recall

RC-2017-RN-00798-1

Class II

2017-06-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00798-1

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).

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.