DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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.govFDA Recall Number: Z-1598-2023
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