🔍 RecallPedia

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Class I - Dangerous
🏥 Medical Devices Recalled: May 22, 2024 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Software versions 1.17 and below, UDI-DI 15099590732103.
  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 reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and 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, Catalog #C11137.

Product Codes/Lot Numbers:

Software versions 1.17 and below, UDI-DI 15099590732103.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2544-2024

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