# Major Recall Alert: Xpert® BCR-ABL Ultra Test Kits Recalled Due to Potential Inaccurate Results with Elevated White Blood Cell Counts
## Why This Recall is Important
A new recall involving the Xpert® BCR-ABL Ultra test kits has raised significant concern among healthcare providers and patients. The issue affects the use of these test kits when handling specimens with markedly elevated white blood cell counts (>30,000 cells/μl). In rare circumstances, this can lead to inaccurate results, jeopardizing proper diagnosis and treatment pathways for chronic myeloid leukemia (CML) and other conditions monitored using this test.
Accurate diagnostic results are a cornerstone of effective treatment planning, making it imperative for healthcare professionals to be aware of this recall and take appropriate precautions. This recall emphasizes patient safety and the importance of reporting and addressing issues with critical medical equipment in a timely manner.
## Details of the Recall
The recall for Xpert® BCR-ABL Ultra test kits, used for monitoring CML through quantitative measurement of the BCR-ABL1 gene transcript, was announced on **[INSERT DATE]**. Below are the key facts related to this recall:
- **Category**: Medical diagnostic kits.
- **Brand**: Xpert®.
- **Product**: BCR-ABL Ultra test kits.
- **Reason for Recall**: In rare cases, using the kits with specimens that have extremely elevated white blood cell counts may produce inaccurate test results.
- **Specific Threshold**: A markedly elevated white blood cell count noted as greater than 30,000 cells/μl.
- **Risks**: Inaccurate diagnostic results could delay proper treatment or result in inappropriate therapeutic decisions.
- **Safety Precautions**: Healthcare providers are advised to carefully evaluate results obtained from specimens with elevated white blood cell counts and follow clinical judgment for confirmation testing.
For the official recall notice or additional details, visit the [Health Canada recall page](https://recalls-rappels.canada.ca/en/alert-recall/xpertr-bcr-abl-ultra).
## What You Should Do
If you or your healthcare organization uses the Xpert® BCR-ABL Ultra test kits, there are immediate steps to take:
- **Verify Inventory**: Check your current stock of Xpert® BCR-ABL Ultra test kits and set aside those affected by this recall.
- **Evaluate Results Carefully**: Ensure any specimens with markedly high white blood cell counts (above 30,000 cells/μl) are analyzed with caution. Consider alternative methods to confirm results if necessary.
- **Contact Customer Support**: Reach out to the manufacturer or distributor for guidance on the next steps, including replacement kits or refunds.
- **Notify Your Team**: Inform personnel handling these kits about the recall to avoid errors during testing.
Patients undergoing testing should consult with their healthcare provider if they have concerns about their results or if additional testing is recommended.
## Stay Safe – Get Instant Recall Alerts
Medical recalls like this emphasize the importance of staying informed to ensure safety and accuracy in diagnostics. With fast-moving recalls and announcements, keeping track can be challenging for both healthcare professionals and individuals.
Download our free **[App Name]** to receive instant recall alerts directly on your smartphone. Stay on top of safety news about medical devices, medications, and health products with real-time notifications.
**Get peace of mind and be proactive about your health – [Download the App Now] (insert app link).**
**Visit Health Canada's official recall page for more information:** [Xpert® BCR-ABL Ultra Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/xpertr-bcr-abl-ultra).
Staying informed saves lives – take action now!