# Major Recall Alert: Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26, Ready-To-Use (Dako Omnis) Recalled Due to Weak Staining in CLL/SLL Tissue Samples
On **July 28, 2025**, a significant recall was issued for the **Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26, Ready-To-Use (Dako Omnis)** due to reports of **weak staining in certain CLL/SLL tissue samples** when the product was used alongside GA604. This recall could have critical implications for medical diagnoses and laboratory outcomes, urging healthcare professionals and laboratories to take immediate action.
Keep reading to learn more about this recall and ensure compliance with safety measures to protect patient health and diagnostic integrity.
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## Why This Recall is Important
This recall spotlights a crucial issue affecting diagnostic accuracy in **chronic lymphocytic leukemia (CLL)** and **small lymphocytic lymphoma (SLL)** tissue sample testing.
The issue stems from **weak staining results** observed in some instances when the product is used for CD20 staining—a critical marker in diagnosing and managing these forms of cancer. Weak staining can lead to:
- **Potential Misdiagnosis**: Key diagnostic information may be missed, reducing the reliability of pathological analysis.
- **Treatment Delays**: Errors in identification of CD20 markers could delay critical treatment decisions.
- **Patient Safety Concerns**: Proper diagnosis is vital for precise and timely patient care.
Given the high stakes involved in oncology and pathology, this recall underscores the **essential role of reliable diagnostic tools in patient safety and healthcare delivery**.
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## Details of the Recall
Below are the key details regarding the affected product and recall specifics:
- **Brand**: Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26, Ready-To-Use (Dako Omnis)
- **Product**: Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26
- **Issue Reported**: Weak staining observed in some CLL/SLL tissue samples.
- **Recall Start Date**: July 28, 2025
- **Reason for Recall**: Product usage resulted in insufficient staining of CD20 markers in specific cases, impacting diagnostic reliability.
- **Action Needed**: Laboratories and clinicians using this product should immediately stop using affected lots and follow relevant safety measures.
To see the official recall notice, please visit the source: **[Recalls and Safety Alerts - Canada.ca](https://recalls-rappels.canada.ca/en/alert-recall/flex-monoclonal-mouse-anti-human-cd20cy-clone-l26-ready-use-dako-omnis)**
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## What You Should Do
If your laboratory or healthcare team uses **Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26, Ready-To-Use (Dako Omnis)**, taking the following steps is crucial:
- **Cease Use Immediately**: Stop using the product for any CLL/SLL testing or related purposes.
- **Review Inventory**: Ensure affected lots or batches are identified and segregated to prevent accidental usage.
- **Contact Manufacturer**: Reach out to the product manufacturer or your supplier for further guidance on replacement or refunds.
- **Report Issues**: Inform relevant health authorities or file a report if any diagnostic concerns have already arisen due to the product.
By acting promptly, laboratories can minimize the risks associated with weak staining and maintain diagnostic reliability.
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## Stay Safe – Get Instant Recall Alerts
In today’s fast-paced medical environment, staying informed about recalls and product safety updates is more critical than ever. **Download our Recall Tracking App** to:
- Receive **real-time notifications** about recalls like this.
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- Protect your patients and healthcare team by staying up-to-date.
Don’t let recalls go unnoticed—download the app now to stay ahead of potential risks!
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The recall of the **Flex Monoclonal Mouse Anti-Human Cd20cy, Clone L26** due to weak staining is a poignant reminder of the importance of quality-driven, consistent diagnostic tools. Laboratories and healthcare providers are encouraged to take swift action to prevent diagnostic mishaps and ensure top-tier patient care. For the **official recall notice**, or further details, visit the official government site: **[Canada Recalls and Alerts](https://recalls-rappels.canada.ca/en/alert-recall/flex-monoclonal-mouse-anti-human-cd20cy-clone-l26-ready-use-dako-omnis)**.