🔍 RecallPedia

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Class I - Dangerous
🏥 Medical Devices Recalled: March 27, 2025 Beckman Coulter Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
  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:
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
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 DxI 9000 Access Immunoassay Analyzer

Product Codes/Lot Numbers:

UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1664-2025

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Class I - Dangerous

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