Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Class I - DangerousWhat Should You Do?
- Check if you have this product: List Number 7K72-20 - ALL LOTS, List Number 7K72-25 - ALL LOTS, and List number 7K72-35 - ALL LOTS.
- 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:
- Abbott Ireland Diagnostics Division
- Reason for Recall:
- Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Product Codes/Lot Numbers:
List Number 7K72-20 - ALL LOTS, List Number 7K72-25 - ALL LOTS, and List number 7K72-35 - ALL LOTS.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1353-2019
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