CanadaThe DxC 500i Clinical Analyzer (catalogue C63521, C63522) with software V.1.3.5 or earlier and the DxC 500 AU Clinical Chemistry Analyzer (catalogue C63520, C63519) with software V.1.4.5 or earlier are affected. A software issue can revert user-configured nondefault units back to system default when activating a draft configuration while testing plasma samples; contact Beckman Coulter, Inc. for 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: Dxc 500i Clinical Analyzer; Lot or serial number: Software V. 1.3.5 or earlier; Model or catalogue number: C63521
Affected products: Dxc 500i Clinical Analyzer; Lot or serial number: Software V. 1.3.5 or earlier; Model or catalogue number: C63522
Affected products: Dxc 500 AU Clinical Chemistry Analyzer; Lot or serial number: Software V. 1.4.5 or earlier; Model or catalogue number: C63520
Affected products: Dxc 500 AU Clinical Chemistry Analyzer; Lot or serial number: Software V. 1.4.5 or earlier; Model or catalogue number: C63519
The hazard
Beckman Coulter identified a software issue affecting DxC 500i and DxC 500 AU Analyzers when testing plasma samples. Following user configuration of a chemistry test to nondefault units, subsequent activation of a draft configuration in the system configuration page may revert units to the system default without notifying the user.
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