One Step 10A in vitro diagnostic test
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905
- 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:
- DFI Co., Ltd.
- Reason for Recall:
- The devices were distributed without required FDA premarket clearance or approval.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
One Step 10A in vitro diagnostic test
Product Codes/Lot Numbers:
UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2082-2026
Related Recalls
Class I - Dangerous
The devices were distributed without required FDA premarket clearance or approval.
Class I - Dangerous
The devices were distributed without required FDA premarket clearance or approval.
Class I - Dangerous
The devices were distributed without required FDA premarket clearance or approval.