# Major Recall Alert: MAS™ Omni-CARDIO™ Recalled Due to Vial-to-Vial Variability with High Sensitivity Troponin I Assays
Microgenics has recently announced the urgent recall of its **MAS™ Omni-CARDIO™ liquid assayed integrated cardiac control** due to **vial-to-vial variability concerns** associated specifically with **high sensitivity troponin I assays**. While other analytes and standard/regular troponin I assays are reportedly unaffected, this variability could lead to **delays in reporting critical patient results**. If you are currently using this product in your lab and the material exceeds your specifications, proper disposal is strongly recommended.
This recall raises important concerns for healthcare facilities and professional laboratories serving cardiac patients. Here’s everything you need to know about the recall and how you can respond effectively.
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## Why This Recall is Important
For heart-related testing, precision is paramount. The MAS™ Omni-CARDIO™ product is designed to act as a cardiac control when conducting diagnostic assays. However, the recently identified issue involving **vial-to-vial variability** could compromise test consistency and reliability **for high sensitivity troponin I assays (hs-TnI assays)**.
- **Troponin I testing** is used to detect cardiac damage and assess heart conditions, including myocardial infarction (heart attack).
- **High sensitivity troponin I assays (hs-TnI)** offer advanced accuracy, making them essential for diagnosing acute cardiac events.
If lab results deviate due to product variability, **diagnosis or treatment for cardiac patients could be delayed**, posing serious implications for patient outcomes.
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## Details of the Recall
Here are the key facts surrounding this product recall:
- **Category**: Medical Laboratory Products – Cardiac Diagnostic Controls
- **Brand Name**: MAS™ Omni-CARDIO™
- **Reason for Recall**: Vial-to-vial variability in the control material when used with **high sensitivity troponin I (hs-TnI assays)**.
- **Note**: Regular/standard troponin I assays and other analytes are **not** impacted.
- **Potential Risk**: Delayed reporting of patient results, potentially leading to delayed treatment or misdiagnosis.
- **Recommendation**: If the **vial variability exceeds your lab's specifications**, the material should be immediately **disposed of**.
For additional details, visit the official recall notice: [MAS™ Omni-CARDIO™ Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/mastm-omni-cardiotm).
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## What You Should Do
If your laboratory uses **MAS™ Omni-CARDIO™** for cardiac testing, follow these safety steps:
1. **Inspect Inventory**
- Check for affected lots of MAS™ Omni-CARDIO™ in your laboratory.
2. **Assess Variability**
- Conduct internal checks on the performance of high sensitivity troponin I assays to assess if vial-to-vial results align with lab specifications.
3. **Dispose of Affected Material**
- If inconsistencies are identified that surpass your lab’s internal quality control standards, dispose of the material immediately.
4. **Notify Staff**
- Inform team members about the recall and instruct them to avoid using the product for **high sensitivity troponin I assays**.
5. **Contact Microgenics**
- For further guidance, contact the manufacturer or distributor representative.
Early action can mitigate risks to patient care and maintain the integrity of diagnostic results.
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## Stay Safe – Get Instant Recall Alerts
Recalls like this one remind us of the importance of staying informed about the products we rely on in healthcare. To receive **automatic safety alerts** regarding recalls and updates for medical and consumer products:
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For further details about this **MAS™ Omni-CARDIO™ recall**, visit the official recall notice here: [Official Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/mastm-omni-cardiotm).
Your vigilance and readiness to respond to recalls help ensure the safety and well-being of your patients and customers. Be informed, act quickly, and stay safe!