🔍 RecallPedia

DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

Class I - Dangerous
🏥 Medical Devices Recalled: April 5, 2023 Beckman Coulter Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6
  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 become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

Product Codes/Lot Numbers:

UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1598-2023

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