🔍 RecallPedia

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

Class I - Dangerous
🏥 Medical Devices Recalled: November 26, 2025 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602
  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 determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
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 UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

Product Codes/Lot Numbers:

A71460: UDI 15099590369224 A71461: UDI 15099590369248 A30260: UDI 15099590341602

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1025-2026

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