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Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay Recall Du...

# Major Recall Alert: Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay Recalled Due to False High Patient Results

Customer safety is paramount, and when laboratory equipment fails to provide accurate results, it can lead to serious clinical concerns. Recently, **Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay** was recalled after multiple reports of false high bicarbonate results in patient samples. These inaccuracies stem from elevated levels of lactate dehydrogenase (LDH) in patient samples, which interfere with the assay results. Keep reading to learn more about this recall, its implications, and what steps you can take to stay informed.

## Why This Recall is Important

Laboratory tests guide critical patient care decisions, which makes accuracy non-negotiable. In this case, the **Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay** produced **false high bicarbonate readings** in some samples due to insufficient precautions outlined in the product's Instructions for Use (IFUs). As elevated LDH levels are common in certain medical conditions, any interference in test results can lead to unnecessary clinical interventions or incorrect diagnoses.

When diagnostic tools fail in accuracy or reliability, healthcare professionals and patients face severe risks, making this recall essential to safeguard patient safety and ensure proper medical care.

## Details of the Recall

Here are the key facts regarding the recall of **Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay**:

- **Category**: Clinical Diagnostic Equipment
- **Product Name**: Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay
- **Recall Trigger**: False high bicarbonate results caused by elevated LDH levels in patient samples.
- **Reason**: The product's **Instructions for Use (IFU)** did not warn users about the potential for LDH interference.
- **Impact**: Potential misdiagnosis or inappropriate treatment due to erroneous bicarbonate test results.
- **Date Announced**: October 2023
- **Customer Complaints**: Reports were made regarding multiple lots of the bicarbonate reagent.

For an official report, you can visit the Canadian recall alert page here: [Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay Recall](https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemistry-system-bicarbonate-co2-assay-0).

![Beckman Coulter Bicarbonate Assay Product Image](https://myrecalls.app/images/products/30292_1760746795.jpg)

## What You Should Do

If you use or are impacted by the **Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay**, take the following steps immediately:

- **Discontinue Use**: Cease usage of any affected bicarbonate reagent lots linked to the recall.
- **Contact Beckman Coulter**: Reach out to the manufacturer for updated product guidance, replacement options, or additional support.
- **Notify Your Lab Team**: Inform all relevant staff and clinicians in your organization to ensure incorrect test results don't affect patient care.
- **Consult Healthcare Professionals**: Patients and providers should discuss measures to mitigate any erroneous diagnoses or treatments resulting from false bicarbonate levels recorded.

Safety in medical diagnostics can never be compromised. Taking these precautions can prevent potential harm resulting from this product issue.

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Staying informed saves lives—it’s that simple. Don’t delay—act on this critical recall alert today to help protect yourself and your patients.

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