ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
- 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:
- TERRAGENE S.A.
- Reason for Recall:
- Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Product Codes/Lot Numbers:
Lot numbers: F40062, F40064, F40072, F40074, F40101, F40116; UDI-DI - 07798375772624 (primary packaging), 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1248-2025
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