# Major Recall Alert: UniCel DxI 600 and DxI 800 Access Immunoassay Systems Recalled Due to Startup Failures
Beckman Coulter is recalling several models of its UniCel DxI 600 and 800 Access Immunoassay Systems due to a critical software and hardware issue that renders the instruments non-functional after rebooting. The failure, stemming from the AuObj.exe software not launching as expected, is confirmed by a specific LED pattern on MCC cards indicating a hardware startup fault. This issue requires intervention by a Field Service Engineer (FSE) to resolve, making the recall a significant event for healthcare facilities relying on these systems.
Read on for everything you need to know about this critical recall and how to take immediate action.
## Why This Recall is Important
The affected UniCel DxI 600 and 800 Access Immunoassay Systems are crucial instruments used in laboratory settings for immunoassay testing. Their failure to restart following a reboot can result in:
- **Testing Delays**: Laboratories unable to perform timely immunoassay tests, potentially affecting patient diagnoses and treatment.
- **Operational Disruptions**: Facilities must contact Beckman Coulter for FSE intervention, causing downtime in operations.
- **Patient Impact Risks**: In critical care scenarios, testing delays could have serious consequences for patient health outcomes.
The recall highlights the importance of reliable medical equipment and timely issue resolution to ensure laboratory efficiency and patient safety.
## Details of the Recall
The recall, announced on 30912, pertains specifically to the following Beckman Coulter UniCel DxI models:
### Affected Devices:
- UniCel DxI 600 Access Immunoassay Sys - Instrument W/ Spot B Gantry Class 2
- UniCel DxI 600 Access Immunoassay Sys - Instrument W/Spot B Gantry Class 3
- UniCel DxI 600 Access Immunoassay System
- UniCel DxI 600 Access Immunoassay System - Instrument Class 2
- UniCel DxI 600 Access Immunoassay System - Instrument Class 3
- UniCel DxI 800 Access Immunoassay - Analyzer-Class 3
- UniCel DxI 800 Access Immunoassay System - Analyzer - Class II
### Reason for Recall:
- **Software Issue**: The AuObj.exe software fails to launch after a reboot.
- **Hardware Fault**: LED patterns on MCC cards confirm a hardware startup failure.
- **Resolution Required**: Only a Beckman Coulter Field Service Engineer (FSE) can resolve this non-conformance issue.
For the official government-issued recall notice, visit [here](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-and-800-access-immunoassay-systems).
## What You Should Do
If your facility uses any of the recalled UniCel DxI 600 or 800 Access Immunoassay Systems, follow these steps:
1. **Identify Affected Models**: Check your inventory for the specific recalled devices listed above.
2. **Contact Beckman Coulter**: Inform the company of your affected model and arrange for FSE intervention to address the issue.
3. **Halt Usage**: Until resolved, avoid rebooting the machines to prevent further operational disruptions.
4. **Follow Official Guidance**: Adhere to any supplemental recommendations provided by Beckman Coulter and health agencies.
Remaining proactive is key to minimizing disruptions and ensuring the continuity of laboratory operations.
## Stay Safe – Get Instant Recall Alerts
Product recalls like this one underscore the importance of staying informed about critical safety notifications. Whether you’re a medical professional, laboratory technician, or healthcare administrator, timely information can help you respond effectively to recalls.
👉 **Stay ahead of safety alerts by downloading the [MyRecalls App](https://myrecalls.app)!** Get instant notifications about product recalls, safety warnings, and updates to keep your team informed and your operations running smoothly.
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To learn more about the UniCel DxI 600 and 800 Access Immunoassay Systems recall, view the [official recall notice here](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-and-800-access-immunoassay-systems). Don’t wait—act now to ensure the safety and efficiency of your laboratory equipment!