# Major Recall Alert: Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay Recalled
The Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay has been officially recalled in Canada. This crucial diagnostic product, used for measuring LDL cholesterol levels, is under scrutiny for not meeting the triglyceride interference claim as outlined in the BAOSR6x96 v10 Instructions for Use (IFU). According to the IFU, the assay should display "no significant interference up to 1,500 mg/dl triglyceride" with recovery within 10% of the initial value. However, this standard is no longer being met, potentially leading to skewed testing results that may affect clinical decisions.
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## Why This Recall is Important
Precise and reliable cholesterol diagnostics, particularly for LDL cholesterol, are vital for managing cardiovascular health. When diagnostic tools do not perform according to specifications, it puts both clinicians and patients at risk. The Beckman Coulter AU Immunochemistry System’s HDL/LDL Cholesterol Assay helps monitor cholesterol levels, playing a critical role in identifying and managing conditions like high cholesterol, heart disease, and related risks.
The failure of this product to meet the "no significant interference" standards under high triglyceride levels is a serious concern. Patients with elevated triglycerides may receive incorrect LDL cholesterol readings, leading to:
- **Misdiagnosis or improper treatment plans**
- **Inaccurate cardiovascular risk assessments**
- **Potential harm to patient health due to incorrect dosage or ineffective therapeutic measures**
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## Details of the Recall
Here are the key details regarding the Beckman Coulter cholesterol assay recall:
- **Category**: Diagnostics and Laboratory Testing
- **Brand**: Beckman Coulter
- **Product**: AU Immunochemistry System- HDL/LDL Cholesterol Assay (LDL cholesterol OSR6x96)
- **Reason for Recall**: The product does not meet the triglyceride interference claim of no significant interference up to 1,500 mg/dl triglyceride as per the BAOSR6x96 v10 Instructions for Use (IFU).
- **Criteria Affected**: The IFU outlines that "no significant interference" means recovery values should remain within 10% of the initial measurement. This expectation is not being achieved.
- **Safety Announcement Date**: October 17, 2023
This recall highlights why manufacturers and healthcare providers must monitor adherence to safety and performance standards for critical diagnostic tools.
For the official Health Canada advisory notice, visit: [Health Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemistry-system-hdlldl-cholesterol-assay)
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## What You Should Do
If your practice or laboratory uses Beckman Coulter's HDL/LDL Cholesterol Assay, take immediate action to ensure patient safety:
1. **Discontinue Use**: Stop using the affected assay (OSR6x96) immediately to avoid inaccurate LDL cholesterol readings.
2. **Contact the Manufacturer**: Reach out to Beckman Coulter for further instructions, resolutions, or possible replacement products.
3. **Consult Healthcare Providers**: If you are a patient who recently underwent cholesterol testing involving this assay, consult your healthcare provider to assess the reliability of your results.
4. **Follow Updates**: Stay informed by monitoring official recall updates via Health Canada or the manufacturer.
Ensuring swift action can mitigate any potential risks stemming from the use of this product.
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## Stay Safe – Get Instant Recall Alerts
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For more information on recall alerts and updates, visit the official recall advisory: [Health Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemistry-system-hdlldl-cholesterol-assay). Stay informed and protect your loved ones!