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Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent Recall Due to Beckma...

# Major Recall Alert: Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent Recalled Due to False High Results Risk

Beckman Coulter has issued a **recall** for lot m404166 of its **Synchron® Systems Direct LDL Cholesterol (LDLD)** reagent (ref 969706) in Canada. This critical health alert was issued as testing with this specific lot could generate **false high LDL cholesterol results**, potentially leading to serious health mismanagement. Read on to learn the details of this recall, its implications, and how you can stay safe.

## Why This Recall is Important

Low-Density Lipoprotein (LDL) cholesterol, often referred to as "bad cholesterol," is a significant indicator of cardiovascular health. Accurate LDL cholesterol results are vital for diagnosing and treating conditions such as heart disease, high cholesterol, and other metabolic disorders.

With the recalled lot (m404166) of the **Synchron® Systems Direct LDL Cholesterol (LDLD) reagent**, **false high readings** may cause:
- **Unnecessary treatments**: Patients may be prescribed medications or advised to adjust their diets based on inaccurate results.
- **Delays in accurate diagnosis**: False results could lead healthcare professionals to overlook the need for additional critical testing.
- **Increased stress or anxiety**: Patients receiving a false diagnosis may endure psychological strain and unnecessary health-related concerns.

It is crucial for healthcare providers and laboratories using this product to stop using affected tests immediately and follow product recall guidelines for patient safety.

## Details of the Recall

Below are the key details regarding this urgent recall:
- **Category**: Medical Device/Diagnostics
- **Brand**: Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent
- **Product Reference**: Ref 969706, Lot Number m404166
- **Reason for Recall**: Beckman Coulter determined that this specific reagent lot may generate **false high LDL cholesterol results**.
- **Issue Identified By**: Laboratory testing and quality assurance conducted by Beckman Coulter.
- **Date Announced**: [October 24, 2023].

For further details, you can visit the official Health Canada recall page here: [Official Recall Notice.](https://recalls-rappels.canada.ca/en/alert-recall/synchronr-systems-direct-ldl-cholesterol-ldld-reagent)

## What You Should Do

If your healthcare facility or diagnostic laboratory uses the **Synchron® Systems Direct LDL Cholesterol (LDLD)** reagent, please follow these steps immediately:
- **Check your inventory**: Verify if lot m404166 is in stock.
- **Stop using the product**: Discontinue the use of any kits from the affected lot immediately.
- **Contact Beckman Coulter**: Reach out to the manufacturer for further instructions regarding replacement or remediation.
- **Inform healthcare providers**: Ensure doctors and patients who may be impacted are informed to reassess recent test results if needed.

For additional guidance, contact **Beckman Coulter customer support** or visit the [official recall page](https://recalls-rappels.canada.ca/en/alert-recall/synchronr-systems-direct-ldl-cholesterol-ldld-reagent).

## Stay Safe – Get Instant Recall Alerts

In today’s fast-paced healthcare environment, staying on top of critical product recalls can be a challenge. To ensure patient safety and eliminate risks, consider downloading a reliable recall notification app that provides real-time updates on product recalls, safety alerts, and advisories.

Take action today! **Download our user-friendly app now** and keep your healthcare facility informed and compliant. Whether you’re a laboratory technician, healthcare provider, or patient, precise information at the right time can make all the difference for health and safety.

_Stay informed. Stay safe._

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