🔍 RecallPedia

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

Class I - Dangerous
🏥 Medical Devices Recalled: May 27, 2024 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2552/Exp. 2025-07-01, 2553/Exp. 2025-10-01, 2554/ Exp. 2026-03-01
  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:
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

Product Codes/Lot Numbers:

UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2552/Exp. 2025-07-01, 2553/Exp. 2025-10-01, 2554/ Exp. 2026-03-01

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2428-2024

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