Recall MonitorHealth Products
UniCel DxI 600 and 800 Access Immunoassay Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: UniCel DxI 600 and 800 Access Immunoassay Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| UniCel DxI 800 Access Immunoassay - Analyzer-Class 3 | More than 10 numbers, contact manufacturer. | A71457 |
| UniCel DxI 800 Access Immunoassay - Analyzer-Class 3 | More than 10 numbers, contact manufacturer. | A71456 |
| UniCel DxI 800 Access Immunoassay - Analyzer-Class 3 | More than 10 numbers, contact manufacturer. | 973100 |
| UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2 | More than 10 numbers, contact manufacturer. | A71460 |
| UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2 | More than 10 numbers, contact manufacturer. | A71461 |
| UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3 | More than 10 numbers, contact manufacturer. | A71460 |
| UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3 | More than 10 numbers, contact manufacturer. | A71461 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 900950 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 902386 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 900807 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 901719 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 902624 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 900570 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 902385 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 902622 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 901684 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 3 | 902475 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 900950 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 902386 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 900807 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 901719 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 902624 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 902385 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 900570 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 902622 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 901684 | A30260 |
| UniCel DxI 600 Access Immunoassay System | 902475 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 900950 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 902386 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 900807 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 901719 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 902624 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 900570 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 902385 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 902622 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 901684 | A30260 |
| UniCel DxI 600 Access Immunoassay System - Instrument Class 2 | 902475 | A30260 |
| UniCel DxI 800 Access Immunoassay System - Analyzer - Class II | More than 10 numbers, contact manufacturer. | A71457 |
| UniCel DxI 800 Access Immunoassay System - Analyzer - Class II | More than 10 numbers, contact manufacturer. | A71456 |
| UniCel DxI 800 Access Immunoassay System - Analyzer - Class II | More than 10 numbers, contact manufacturer. | 973100 |
Issue
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.