CanadaBeckman Coulter AU Immunochemistry System – AU480 Analyzer units with serial numbers 2021104332, 2021124493, 2022014627, 2021124487 and 2022014611 are affected. A software defect in AU480 analyzers using Microsoft SQL Server 2022 Express may cause a DB connection error that renders alarmDB unreadable, prevents instrument startup, and may delay reporting patient test results to physicians. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, California, United States, 92821.
How to identify it
Affected products: Beckman Coulter AU Immunochemistry System - AU480 Analyzer; Lot or serial number: 2021104332; Model or catalogue number: AU480
Affected products: Beckman Coulter AU Immunochemistry System - AU480 Analyzer; Lot or serial number: 2021124493; Model or catalogue number: AU480
Affected products: Beckman Coulter AU Immunochemistry System - AU480 Analyzer; Lot or serial number: 2022014627; Model or catalogue number: AU480
Affected products: Beckman Coulter AU Immunochemistry System - AU480 Analyzer; Lot or serial number: 2021124487; Model or catalogue number: AU480
Affected products: Beckman Coulter AU Immunochemistry System - AU480 Analyzer; Lot or serial number: 2022014611; Model or catalogue number: AU480
The hazard
Beckman Coulter has determined that a software defect in AU480 chemistry analyzers using Microsoft® SQL server 2022 express may cause a DB connection error that renders alarmDB unreadable and prevents instrument startup. The issue is associated with transaction log auto-growth, and may cause delays in reporting patient test results to physicians.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States