AIA-PACK TgAb CONTROL SET
Class I - DangerousWhat Should You Do?
- Check if you have this product: TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.
- 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:
- The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AIA-PACK TgAb CONTROL SET
Product Codes/Lot Numbers:
TgAb: G644899 Expires June 2017; G844801 Expires August 2017 & GX44802 Expires 09/30/2017.
Distribution:
Distributed in: AK, FL, GA, MA, NY, OH, OK, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2169-2017
Related Recalls
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
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%.
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%.