Product: STA Liatest D-Di; REF: 00515;
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
- 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:
- Diagnostica Stago, Inc.
- Reason for Recall:
- A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Product: STA Liatest D-Di; REF: 00515;
Product Codes/Lot Numbers:
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0205-2026
Related Recalls
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.