Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00630414596310 Lot Numbers: 232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365
- 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:
- Siemens Healthcare Diagnostics, Inc.
- Reason for Recall:
- Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin 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:
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
Product Codes/Lot Numbers:
UDI-DI: 00630414596310 Lot Numbers: 232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3169-2024
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