Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
- 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:
- Future Diagnostics Solutions B.V.
- Reason for Recall:
- Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Product Codes/Lot Numbers:
Catalog Number: 4K-IPT-00 UDI-DI: 08719326045214-230915 Lot Numbers: M78559 M78560 M78636
Distribution:
Distributed in: US, AZ, CA, CO, LA, OH, PA, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1016-2023