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Asserachrom® HPIA Recall Due to After receiving three customer complaints (fr...

# Major Recall Alert: Asserachrom® HPIA Recalled Due to Product Defect in Reagent Strips

Healthcare professionals and laboratories using the Asserachrom® HPIA diagnostic kits are being urged to take immediate action following a safety recall announcement by Stago. Lot 271288 of the Asserachrom® HPIA product is being recalled due to a defect in approximately 5% of its reagent 1 strips. This defect results in false negative results, impacting the reliability of tests and potentially compromising patient care.

If you're using this product, here's everything you need to know about the recall, why it matters, and what you should do next.

## Why This Recall is Important

Faulty diagnostic products can lead to inaccurate test results, putting patient safety at serious risk. In the case of Asserachrom® HPIA lot 271288, defective reagent 1 strips can produce false negative results across every well within the impacted strip.

Here's why this recall is critical to address:

- **Impact on Test Results**: Kit reference reagent 6 and control 2 (reagent 7b) produce low optical density (OD) readings, which mimic those of control 1 (reagent 7a). This defect prevents the test values from meeting the assigned requirements outlined for the lot.
- **Potential for Patient Risk**: False negative results may delay or misguide clinical decisions, which could be life-threatening in certain scenarios.
- **Global Scope**: Although complaints initially came from outside the US and Canada, this recall emphasizes a worldwide need for vigilance as users anywhere may potentially have affected products.

The recall has been issued as a precaution to protect end users and ensure compliance with safety standards.

## Details of the Recall

This recall pertains specifically to **lot 271288** of the Asserachrom® HPIA product. Below are the most pertinent details:

- **Brand**: Asserachrom® HPIA
- **Product**: Diagnostic reagents packaged with **reagent 1 strips**
- **Recall Reason**: Reports confirmed approximately 5% of the reagent 1 strips in this lot are defective, causing inaccurate readings.
- Every well in the faulty strips produces negative results.
- Reagent 6 and control 2 readings are inconsistent with expected values as outlined in the lot's assigned value sheet.
- **Release Date of Recall**: October 31, 2023
- **Source**: [Official Recall Notice from Recalls-Rappels Canada](https://recalls-rappels.canada.ca/en/alert-recall/asserachromr-hpia)

For anyone using this lot in clinical or laboratory settings, take immediate action to avoid unintended clinical consequences.

## What You Should Do

If you currently have Asserachrom® HPIA lot 271288 in your inventory, follow these steps to address the issue:

- **Stop Using the Product**: Immediately cease usage of all affected products from lot 271288.
- **Dispose of Affected Products**: Safely dispose of any remaining inventory following local disposal regulations for medical products.
- **Submit the Acknowledgement Form**: Complete and sign the recall acknowledgement form provided by the manufacturer or distributor, and return it as instructed.

For further clarification or support, contact Stago or the distributor who supplied the product.

## Stay Safe – Get Instant Recall Alerts

To stay updated on important recalls like this, we highly recommend subscribing to recall notifications or downloading trusted apps that provide real-time alerts. Staying informed ensures that your organization can respond promptly to safety announcements, protecting both patient outcomes and operational integrity.

Stay proactive and safeguard your practice by downloading our **Recall Alert App**, which delivers instant updates on product recalls in your industry.

For official details on the Asserachrom® HPIA recall, visit the [Recalls-Rappels Canada website](https://recalls-rappels.canada.ca/en/alert-recall/asserachromr-hpia).

Protecting patient safety begins with awareness. Take action today and stay one step ahead of potential risks in your healthcare operations!

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