# Major Recall Alert: Inhibin B Gen II ELISA Recalled Due to Elevated Results
Beckman Coulter has issued a critical recall for its **Inhibin B Gen II ELISA reagent lots**, effective **February 17, 2025**. The recall was triggered after the company discovered that the affected reagent kits can provide **elevated results**, which are not detectable through kit controls. According to investigational data, the average increase in test results is approximately **15%**, with the highest reported increase reaching **+44%** for an individual sample.
This issue could potentially lead to incorrect clinical interpretations, making it a serious concern for healthcare professionals and patients alike.
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## Why This Recall is Important
Accurate test results are critical for effective healthcare diagnosis and decision-making. The **Inhibin B Gen II ELISA test** is commonly used to measure **Inhibin B levels in biological samples**, which plays a role in evaluating reproductive health and other medical conditions.
The discovery of **elevated results in affected reagent lots** raises major concerns, as:
- It **compromises diagnostic reliability**, potentially leading to inappropriate medical follow-ups.
- The issue is **not detectable by kit controls**, meaning users of these kits may assume their results are accurate.
- With reported elevations of up to **44% for individual samples**, the margin of error is significant.
Healthcare providers and diagnostic labs rely on the integrity of such tests, which makes this recall particularly urgent.
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## Details of the Recall
Here’s what you need to know about the **Inhibin B Gen II ELISA recall**:
- **Product Name**: Inhibin B Gen II ELISA
- **Brand**: Beckman Coulter
- **Issue**: Elevated test results that cannot be detected by built-in kit controls
- **Average Increase**: +15% (with some cases reaching +44%)
- **Recall Start Date**: February 17, 2025
- **Official Announcement**: February 17, 2025
For further clarification, consumers and healthcare providers may refer to the **[official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/inhibin-b-gen-ii-elisa)**.
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## What You Should Do
If you currently own or use the **Inhibin B Gen II ELISA reagent kits**, take the following precautions immediately:
1. **Stop Using/Distributing**: Discontinue use of any potentially affected lots identified in the recall notice.
2. **Contact Beckman Coulter**: Reach out to the manufacturer for further guidance, including replacement instructions or refunds.
3. **Inform Stakeholders**: Advise all relevant staff, healthcare professionals, or facilities using the kits about the recall.
4. **Verify Results**: Review patient test results obtained using the affected lots. Consider conducting confirmatory testing if required.
5. **Monitor Updates**: Stay updated with additional announcements or instructions issued by Beckman Coulter.
By responding promptly to the recall, healthcare providers can help prevent misdiagnosis and mitigate risks to their patients.
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## Stay Safe – Get Instant Recall Alerts
Product recalls, especially those involving medical devices, can have a significant impact on public health. The **Inhibin B Gen II ELISA recall** highlights the importance of staying informed about defective or faulty products in your industry.
Stay ahead of recalls and safety alerts by downloading the **[My Recalls App](https://myrecalls.app)**! With this easy-to-use app, you’ll receive **real-time notifications** about recalls for consumer products, medical devices, and more. Protect yourself, your family, and your business by staying informed.
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For more information on this recall, visit the official recall notice here: [Inhibin B Gen II ELISA Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/inhibin-b-gen-ii-elisa).
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