🔍 RecallPedia

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Class I - Dangerous
🏥 Medical Devices Recalled: February 5, 2025 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 15099590732103; Serial Numbers: 300116-300117, 300123-300124, 300126, 300128-300139, 300141-300145, 300147- 300158, 300160-300164, 300166-300179, 300181-300183, 300186, 300188-300195, 300197-300207, 300209-300250, 300252- 300256, 300258-300259, 300261, 300263- 300264, 300266-300277, 300279-300290, 300291, 300293-300299, 300300-300309, 300312-300352
  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:
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Product Codes/Lot Numbers:

UDI-DI: 15099590732103; Serial Numbers: 300116-300117, 300123-300124, 300126, 300128-300139, 300141-300145, 300147- 300158, 300160-300164, 300166-300179, 300181-300183, 300186, 300188-300195, 300197-300207, 300209-300250, 300252- 300256, 300258-300259, 300261, 300263- 300264, 300266-300277, 300279-300290, 300291, 300293-300299, 300300-300309, 300312-300352

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1388-2025

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