🔍 RecallPedia

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Class I - Dangerous
🏥 Medical Devices Recalled: September 17, 2025 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beckman Coulter Inc.
Reason for Recall:
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Product Codes/Lot Numbers:

REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0441-2026

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