Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
- 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:
- Tosoh Bioscience, Inc.
- Reason for Recall:
- Instructions For Use had incorrect lot number and calibrator values
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Product Codes/Lot Numbers:
Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2282-2016
Related Recalls
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Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.