CanadaBeckman Coulter UniCel DxI 600 and 800 Access Immunoassay Systems (models/catalogue numbers include A71457, A71456, 973100, A71460, A71461, A30260 and various serial/lot numbers such as 900950, 902386, 900807, 901719, 902624, 900570, 902385, 902622 or others—contact the manufacturer for serials listed as “more than 10 numbers”). A software failure (AuObj.exe not launching) can prevent the instruments from starting after a reboot and a specific LED pattern on MCC cards confirms a hardware startup fault that requires field service engineer intervention. Contact the manufacturer 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: UniCel DxI 800 Access Immunoassay - Analyzer-Class 3; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71457
Affected products: UniCel DxI 800 Access Immunoassay - Analyzer-Class 3; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71456
Affected products: UniCel DxI 800 Access Immunoassay - Analyzer-Class 3; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 973100
Affected products: UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71460
Affected products: UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71461
Affected products: UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71460
Affected products: UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71461
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 900950; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 902386; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 900807; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 901719; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 902624; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 900570; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 902385; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 902622; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 901684; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 3; Lot or serial number: 902475; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 900950; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 902386; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 900807; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 901719; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 902624; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 902385; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 900570; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 902622; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 901684; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System; Lot or serial number: 902475; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 900950; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 902386; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 900807; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 901719; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 902624; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 900570; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 902385; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 902622; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 901684; Model or catalogue number: A30260
Affected products: UniCel DxI 600 Access Immunoassay System - Instrument Class 2; Lot or serial number: 902475; Model or catalogue number: A30260
Affected products: UniCel DxI 800 Access Immunoassay System - Analyzer - Class II; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71457
Affected products: UniCel DxI 800 Access Immunoassay System - Analyzer - Class II; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A71456
Affected products: UniCel DxI 800 Access Immunoassay System - Analyzer - Class II; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 973100
The hazard
Beckman Coulter UniCel DxI 600 and 800 instruments fail to start after rebooting because the AuObj.exe software does not launch. A specific LED pattern on MCC cards confirms a hardware startup fault. This non-conformance requires FSE intervention.
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