# Major Recall Alert: UniCel DxI 600 Access Immunoassay System-Total T4 Assay Recalled Due to Calibration Error
The UniCel DxI 600 Access Immunoassay System-Total T4 Assay has recently been issued a recall following the discovery of negative bias in Access Total T4 calibrator lots (PN 33805) when used on DxI 600/800 instruments. This critical issue leads to slopes outside product specifications and poses a medium safety risk, as it could result in false low patient results. Here’s what you need to know about this recall and how you can take quick action to protect patient safety.
## Why This Recall is Important
The accuracy and reliability of diagnostic tools are essential, especially when it comes to assessing thyroid health. The UniCel DxI 600 Access Immunoassay System-Total T4 Assay is widely used to measure total T4 levels in patient samples, which is critical for diagnosing and managing thyroid conditions.
This recall stems from a calibration error in certain lots of the Access Total T4 calibrator (PN 33805). When affected calibrator lots are used on DxI 600/800 instruments, they exhibit a negative bias. Specifically, the slopes fall outside the product’s standard specifications. This issue can lead to false low T4 results, potentially resulting in:
- Misdiagnosis of thyroid disorders
- Unnecessary treatment for hypothyroidism
- Delayed or improper medical interventions
Given these risks, the issue presents a medium safety concern, making it vital for healthcare providers to address the recall promptly to ensure patient safety.
## Details of the Recall
**Here are the key details of the UniCel DxI 600 Access Immunoassay System-Total T4 Assay recall:**
- **Brand Name**: UniCel DxI 600 Access Immunoassay System-Total T4 Assay
- **Product Name**: Access Total T4 Calibrator Lots (PN 33805)
- **Issue**: Negative bias on DxI 600/800 instruments, slopes fall outside product specifications
- **Safety Risk**: Medium (false low total T4 results)
- **Date Announced**: 31,690
- **Recall Scope**: Potential impact on diagnostic accuracy
This calibration issue prompts healthcare providers to review and validate their testing procedures to prevent false low results from affecting clinical decisions.
For official recall details, visit the [Government of Canada recall notice](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoassay-system-total-t4-assay).
## What You Should Do
If you work in a clinical laboratory or healthcare setting that uses the UniCel DxI 600 Access Immunoassay System-Total T4 Assay, follow these steps:
1. **Check Product Inventory**: Identify and isolate affected Access Total T4 calibrator lots (PN 33805).
2. **Stop Use Immediately**: Discontinue using the recalled lots to prevent inaccurate test results.
3. **Notify Healthcare Teams**: Communicate with clinical staff about the potential risk of false low T4 results.
4. **Contact the Manufacturer**: Reach out to your supplier or manufacturer for replacement calibrators and further instructions.
5. **Track Patient Results**: If you suspect that false results have influenced treatment plans, follow up with patients and reassess as needed.
Ensuring accuracy in diagnostic testing is critical. Do not overlook this recall, as it could have significant repercussions on patient care.
## Stay Safe – Get Instant Recall Alerts
Recalls like this highlight the importance of staying informed about the tools and devices used in clinical settings. Don’t let critical safety alerts slip through the cracks—ensure you’re the first to know about recalls and safety updates with our easy-to-use Recall Alert App! Download today to receive instant notifications for crucial updates like this one.
[**Download the Recall Alert App Now**]
For more information about this recall, visit the official announcement here: [UniCel DxI 600 Access Immunoassay System-Total T4 Assay Recall](https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-access-immunoassay-system-total-t4-assay). Stay proactive and help safeguard patient safety!