Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its PK7300 Automated Microplate System.

The manufacturer 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.

The above issue may lead to false negative test results with blood grouping reagents. 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).

The manufacturer advises users to take the following actions:-

• Verify that the following are all set on all PK7300 analyzers in the laboratory:
  • Alarm Volume and Limit Volume in the Common Test Parameter -Name (Reagent tab) menu.
  • 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 the laboratory, affected users should follow the instructions in the PK7300 User's Guide and the information provided by the manufacturer to set them.
• When users place the reagent vials in the reagent tray, they should make sure that each vial is fully seated to the bottom of the tray.

The manufacturer will update the PK7300 User's Guide to include the information described in the actions above to indicate that the settings for the alarm volume, limit volume and associated mode shift are required. Additionally, a statement will be added to insure that the reagent vials are fully seated to the bottom of the reagent tray.

According to the local supplier, the affected products are distributed in Hong Kong

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 27 June 2017