🔍 RecallPedia

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Class I - Dangerous
🏥 Medical Devices Recalled: August 13, 2025 Beckman Coulter Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDIs: 15099590672423, 15099590381646, 15099590687922/ Serial Numbers: AT38527, AU02008, AU10078, AV28630, AW13187, AW29123, BC18100, RBB03201, AW43276, AY06074, AY06092, AY41556, AY43605, AZ02030, AZ03041, AZ18245, AZ22329, AZ39513, AZ46681, BA03048, BA03050, BA03055, BA03060, BA07061, BA07062, BA13227, BA15245, BA27414, BB16181, BB29286, BC08036, BC18099, AZ25376, BB25262, BB25261, BA25393
  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:
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

Product Codes/Lot Numbers:

UDIs: 15099590672423, 15099590381646, 15099590687922/ Serial Numbers: AT38527, AU02008, AU10078, AV28630, AW13187, AW29123, BC18100, RBB03201, AW43276, AY06074, AY06092, AY41556, AY43605, AZ02030, AZ03041, AZ18245, AZ22329, AZ39513, AZ46681, BA03048, BA03050, BA03055, BA03060, BA07061, BA07062, BA13227, BA15245, BA27414, BB16181, BB29286, BC08036, BC18099, AZ25376, BB25262, BB25261, BA25393

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2574-2025

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