🔍 RecallPedia

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Class I - Dangerous
🏥 Medical Devices Recalled: June 25, 2025 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 15099590369231; Serial Numbers: 608109
  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 the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

Product Codes/Lot Numbers:

UDI-DI: 15099590369231; Serial Numbers: 608109

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2267-2025

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Beckman Coulter

Class I - Dangerous

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