# Major Recall Alert: DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, DxI 9000 Access Immunoassay Analyzer Recalled Due to Software Anomaly
A significant recall has been issued for the DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, and DxI 9000 Access Immunoassay Analyzer due to a software anomaly confirmed by Beckman Coulter. This malfunction can prevent accurate application of user-specified manual dilution factors, potentially resulting in erroneous test results or delays in reporting. These issues can disrupt patient care, increasing the risk of misdiagnosis.
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## Why This Recall is Important
Beckman Coulter has identified a critical software issue in their widely used DxC 500i and DxI 9000 analyzers. The software malfunction occurs when additional tests are ordered for samples already "In Progress" that share the same "Sample ID number." Instead of applying the correct manual dilution factors as specified by users, this anomaly may result in:
- **False Low Results (R1)**: Lab results showing artificially low values.
- **False High Results (R2)**: Lab results showing artificially high values.
- **Delays in Reporting (R3)**: Disruptions in lab workflows and delayed delivery of critical test results.
If undetected, these issues can lead to misinterpretation of patient test results, causing potential harm through delayed treatments or erroneous diagnoses.
With clinical laboratories relying on the DxC 500i and DxI 9000 systems for accurate testing, this update is a priority for healthcare facilities, clinicians, and patients alike.
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### Details of the Recall
Here’s what you need to know about the affected products:
- **Category**: Laboratory and Clinical Analyzers
- **Brand**: Beckman Coulter DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, DxI 9000 Access Immunoassay Analyzer
- **Date Announced**: September 2023
- **Affected Issue**: Software anomaly impacting manual dilution factor functionality for specific test scenarios.
- **Potential Risk**: False patient results (low or high) and reporting delays.
For more information, refer to the official recall notice from the Government of Canada [here](https://recalls-rappels.canada.ca/en/alert-recall/dxc-500i-clinical-analyzer-and-dxi-9000-access-immunoassay-analyzer).
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### What You Should Do
If your lab or clinic uses any of the affected analyzers listed, Beckman Coulter recommends taking immediate action to mitigate risks:
1. **Contact Beckman Coulter Support**: Reach out to your Beckman Coulter representative to confirm whether your systems are impacted and seek guidance on next steps.
2. **Follow Manufacturer Safety Measures**: Beckman Coulter is issuing instructions on how to address this issue. Implement these safeguards without delay.
3. **Verify Results**: Consider revalidating recent sample results that involved manual dilution factors, especially for critical diagnostics.
4. **Stay Alert for Updates**: Ensure ongoing communication with Beckman Coulter regarding patches, updates, or recalls.
This recall highlights the importance of vigilance in laboratory operations and maintaining reliable systems in areas where patient safety is paramount.
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### Stay Safe – Get Instant Recall Alerts!
Keeping up with product recalls is essential to protect your patients and your practice. Download our free recall alert app to receive instant notifications about critical recalls like this one, helping you act quickly to prevent patient harm.
Stay informed, stay proactive, and stay safe.
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For further details on this recall, visit the official Government of Canada recall site [here](https://recalls-rappels.canada.ca/en/alert-recall/dxc-500i-clinical-analyzer-and-dxi-9000-access-immunoassay-analyzer).
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Don’t wait—be proactive in ensuring your testing systems are reliable and compliant!