# Major Recall Alert: Elecsys® Anti-TSHR Recalled Due to Test Result Variability
Roche Diagnostics has issued an important recall for its Elecsys® Anti-TSHR assay, citing two major issues identified during internal reviews. This recall affects specific reagent kits used on Cobas diagnostic platforms, including Cobas e 801, e 402, and e 411. Variability in patient test results has been confirmed across different instrument platforms and calibrator lots, posing potential risks for accurate diagnostics.
If your facility uses Elecsys® Anti-TSHR, here’s what you need to know about this recall, its implications, and steps to ensure patient safety.
## Why This Recall is Important
The accuracy and reliability of diagnostic tests are crucial for proper patient care. The Elecsys® Anti-TSHR assay is used to aid in detecting thyroid disorders, making precision vital for accurate diagnosis and treatment. Roche’s internal investigation confirmed:
- **Result variability between instrument platforms** (Cobas e 801/e 402 vs. Cobas e 411).
- **Inconsistent results between calibrator lots**, affecting the Cobas e 411 platform.
These issues could lead to misdiagnosis or delayed treatment in patients, particularly those with thyroid-related conditions. This underscores the importance of removing impacted reagent kits from use immediately to maintain diagnostic accuracy.
## Details of the Recall
Roche has voluntarily recalled all Elecsys® Anti-TSHR assay reagents still in inventory due to confirmed variability issues. Here are the key details:
- **Product Name**: Elecsys® Anti-TSHR Assay
- **Affected Platforms**:
- Cobas e 801
- Cobas e 402
- Cobas e 411 (specific calibrator lots impacted)
- **Issues Identified**:
- Variability in results when the same patient sample is tested across different instrument platforms.
- Inconsistent results when using calibrator lots specific to the Cobas e 411 platform.
- **Recall Date**: October 30, 2023
- **Action Taken by Roche**:
- Free replacement of all affected reagents still in inventory.
- Newly manufactured lots are confirmed to be unaffected and safe for use.
For the official recall notice, visit the [Government of Canada Recalls Website](https://recalls-rappels.canada.ca/en/alert-recall/elecsysr-anti-tshr).
## What You Should Do
If you own or operate Roche diagnostic platforms, here are the steps you need to take immediately:
1. **Stop using affected reagents**: Determine whether your facility has any impacted Elecsys® Anti-TSHR assay lots in inventory.
2. **Contact Roche for replacements**: Reach out to Roche Diagnostics to arrange free replacements for affected reagents.
3. **Inspect and verify lots**: Ensure any newly received reagent kits are from the updated, unaffected production lots.
4. **Communicate with lab teams**: Inform laboratory personnel about the recall and provide updated protocols to prevent usage of faulty reagents.
Prompt action is critical to avoid inaccurate diagnostic results and ensure patient safety. Roche’s customer service team is available to assist with replacements and any further instructions.
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In conclusion, Roche’s proactive recall of the Elecsys® Anti-TSHR assay demonstrates its commitment to diagnostic accuracy and patient safety. If you use this product, act swiftly to remove affected reagents from your inventory and request replacements. For further details, read the official recall notice [here](https://recalls-rappels.canada.ca/en/alert-recall/elecsysr-anti-tshr). Stay vigilant and keep your patients safe!