# Major Recall Alert: Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC) Recalled Due to Hemoglobin Interference Issues
On July 1, 2025, a significant recall was announced for the Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC). The issue stems from a performance concern with the UIBC OSR61205 product, which fails to meet the hemoglobin interference claims specified in the product guidelines. This could lead to inaccurate lab results and potentially affect decisions made in clinical applications. Here's everything you need to know about the recall, why it matters, and how to stay safe.
## Why This Recall is Important
The Beckman Coulter Au Immunochemi Sys- UIBC is widely used in medical labs to help assess unsaturated iron-binding capacity, a crucial parameter for diagnosing iron-related conditions. However, the UIBC OSR61205 reagent is not performing as intended under specific conditions, raising serious concerns:
- **Interference issue:** As per the product’s instructions for use (IFUs), the claim is less than 10% interference up to 2g/L haemoglobin. While the high pool data meets this requirement, the low pool data has shown discrepancies, failing specifications with results of **-43.63%** or **-8.95 µmol/L**.
- **Implications:** This failure could lead to inaccurate diagnostic outcomes in certain cases, especially when low hemoglobin interference levels are critical to test results.
Healthcare providers rely on accurate diagnostics to deliver quality patient care. Any discrepancy in performance can compromise these efforts, making it crucial to address the issue at hand swiftly and effectively.
### Details of the Recall
Here are the key details concerning the recall of the Beckman Coulter Au Immunochemi Sys- UIBC:
- **Affected Product:** Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)
- **Reagent Involved:** UIBC OSR61205
- **Reason for Recall:** Hemoglobin interference claims not being met in low pool data
- **Significant Findings:** Low pool failure recorded at **-43.63%** or **-8.95 µmol/L** instead of the specified <10%.
- **Recall Start Date:** July 1, 2025
- **Image of Product:**
- **Official Source:** [Government of Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemi-sys-unsaturated-iron-binding-capacity-uibc)
### What You Should Do
If your lab or healthcare facility uses the Beckman Coulter Au Immunochemi Sys, it’s important to take the following actions immediately:
- **Cease using the UIBC OSR61205 reagent** until further instructions are provided by Beckman Coulter.
- **Contact the supplier or manufacturer** to verify whether your reagent is part of the affected batch.
- **Monitor for updates and guidance** from Beckman Coulter or health authorities.
- **Communicate with your team and clients** about any potential delays or re-tests necessary due to this issue.
By taking these steps, you can help mitigate potential risks tied to inaccuracies in diagnostic results caused by the product's failure to meet hemoglobin interference specifications.
### Stay Safe – Get Instant Recall Alerts
Product recalls like this one can have significant healthcare and safety implications. Protect your business, team, and clients by staying informed.
**Download the [MyRecalls](https://myrecalls.app) app** to get instant alerts on product recalls and safety warnings. With real-time notifications, you'll always be a step ahead in managing risks and ensuring compliance.
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This recall of the Beckman Coulter Au Immunochemi Sys- UIBC highlights the importance of constant vigilance when it comes to medical technology. Make sure you’re prepared by acting quickly, remaining informed, and prioritizing safety today. For official recall details, visit the [Government of Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemi-sys-unsaturated-iron-binding-capacity-uibc).
Stay proactive. Stay safe.