# Major Recall Alert: Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay Recalled Due to High Patient Results Using Lot 439163
A critical recall has been issued for the **Unicel Dxi 600 Access Immunoassay System - Thyroglobulin Assay** after reports surfaced of **high patient results** when utilizing the **access thyroglobulin reagent pack lot 439163**. The issue was identified as part of an internal review, which revealed that this was the first lot manufactured using antibodies produced by **BEC**, instead of sourcing from a third-party supplier.
The recall officially began on **July 2, 2025**, and serves as an important reminder to healthcare providers and laboratories about ensuring patient safety when using diagnostic equipment. If you or your organization utilizes this product, continue reading for all the details and necessary safety measures.
For official recall information, click here: [Government of Canada Recall Alert](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoassay-system-thyroglobulin-assay).
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## Why This Recall is Important
The **Unicel Dxi 600 Access Immunoassay System - Thyroglobulin Assay** plays a critical role in accurately detecting thyroglobulin levels, which are essential for diagnosing and monitoring thyroid-related conditions, including thyroid cancer.
The issue at hand is that **patients may have received high results**, which can lead to:
- **Unnecessary interventions:** High thyroglobulin levels could result in additional, potentially invasive testing like biopsies, or even unnecessary treatments.
- **Emotional distress:** Patients may face undue stress due to inaccuracies in test results.
- **Extended treatment plans:** Misdiagnosis could delay appropriate care or lead to incorrect adjustments in ongoing treatments.
Healthcare professionals must act promptly to prevent further impact on patient health.
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## Details of the Recall
- **Product Brand:** Unicel Dxi 600 Access Immunoassay System
- **Product Name:** Thyroglobulin Assay
- **Affected Lot:** Access thyroglobulin reagent pack lot **439163**
- **Issue:** Customers reported **high patient test results**, linked to the use of antibodies produced by **BEC**, marking a significant departure from third-party manufacturing standards previously in place.
- **Recall Start Date:** **July 2, 2025**
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## What You Should Do
To mitigate the risks associated with this product defect, follow these instructions:
- **Cease use immediately:** If you are using the Unicel Dxi 600 reagent pack lot 439163, discontinue use.
- **Contact the manufacturer:** Reach out to the supplier or manufacturer for guidance on product returns and refunds.
- **Notify your patients:** If impacted test results were shared with patients, ensure open communication and schedule follow-up testing as necessary.
- **Report Issues:** File a report with [Health Canada's recall alert system](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoassay-system-thyroglobulin-assay) or your local medical device regulatory body.
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## Stay Safe – Get Instant Recall Alerts
With so many products on the market, staying informed about recalls can be challenging. To protect your patients and practice from potential risks:
- Download our **Recall Monitoring App** for real-time updates.
- Gain instant insights into recalls affecting medical devices, consumer products, pharmaceuticals, and more.
**Stay proactive. Stay safe. Download the app today to protect what matters most.**
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**Final Reminder:** If you or your organization relies on the **Unicel Dxi 600 Access Immunoassay System - Thyroglobulin Assay**, take immediate action to ensure patient health and safety. For further information, visit the official recall page: [Government of Canada Recall Alert](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoassay-system-thyroglobulin-assay).