# Major Recall Alert: DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, DxC 500i Au Chemistry Module Recalled Due to Testing Issue
On **August 4, 2025**, a critical product recall was launched by **Beckman Coulter** affecting their **DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, and related systems**. The recall stems from a serious issue affecting testing reliability when clinical chemistry (CC) combination tests and immunoassay (IA) tests are conducted simultaneously. This issue means results from the CC tests may remain "in progress" indefinitely without generating an error alert, which could delay critical patient results.
Read on to learn why this recall matters and what steps you need to take.
## Why This Recall is Important
Accurate and timely lab results are crucial in the healthcare sector to ensure effective patient treatment and diagnosis. The malfunction in the DxC 500i Clinical Analyzer compromises this dependability by leaving clinical chemistry (CC) test results in an "in-progress" state without error notifications. This issue poses several risks, including:
- **Delayed Test Results**: Medical teams might not have access to vital diagnostic information in a timely manner.
- **Potential Misdiagnoses**: Incomplete or stuck test statuses could lead to inappropriate treatment decisions.
- **Decreased Lab Efficiency**: Additional time and resources may be required to resolve the issue manually, hampering workflow.
The recall prioritizes patient safety and the reliability of diagnostic processes in clinical settings. Beckman Coulter urges all affected facilities to take immediate action.
## Details of the Recall
Here’s what you need to know about the recall:
- **Products Affected**:
- DxC 500i Clinical Analyzer
- DxC 500i Access 2 Immunoassay Module
- DxC 500i Au Chemistry Module
- **Reason for Recall**: When ordering clinical chemistry (CC) combination tests concurrently with immunoassay (IA) tests, the IA test may interrupt CC processes, leaving CC test statuses "in progress" without producing an error alert.
- **Date of Recall**: The recall began on **August 4, 2025**.
This issue could occur across all DxC 500i modules, creating potential safety risks in clinical laboratories utilizing these devices.
For an official announcement from Health Canada, visit the [recall notice here](https://recalls-rappels.canada.ca/en/alert-recall/dxc-500i-clinical-analyzers).
## What You Should Do
Healthcare organizations and laboratories using the affected products should act immediately. Here are the recommended steps:
1. **Stop Using Affected Systems**: Discontinue the use of DxC 500i Clinical Analyzer and associated modules for simultaneous clinical chemistry and immunoassay testing.
2. **Contact Beckman Coulter**: Reach out directly to the manufacturer for guidance on resolving the issue or for potential system fixes.
3. **Monitor Pending Tests**: Ensure any tests conducted on these systems are manually verified for completion.
4. **Follow Manufacturer Instructions**: Beckman Coulter is expected to issue additional safety measures or updates to rectify the malfunction. Stay tuned for further communication from the company.
Prompt action can help mitigate risks and maintain the integrity of diagnostic results.
## Stay Safe – Get Instant Recall Alerts
Protecting patients begins with staying informed. Sign up for automated safety alerts and recalls to ensure your facility remains up-to-date on vital information like this.
For Canadians, download the **Recalls and Safety Alerts App** from Health Canada today. Receive **real-time notifications** about product recalls that could affect your organization.
[Download the app here](https://recalls-rappels.canada.ca/en/alert-recall/dxc-500i-clinical-analyzers) and put safety first.
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**Final Thoughts**: Beckman Coulter’s recall of the DxC 500i Clinical Analyzer highlights the importance of robust product safety protocols in diagnostic systems. Don’t delay—take action now to ensure your equipment meets the highest safety standards and protects patient health.
Stay informed, stay vigilant, and keep your diagnostics on track. **Click here** to read more about the recall in-depth: [official announcement](https://recalls-rappels.canada.ca/en/alert-recall/dxc-500i-clinical-analyzers).