13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Codes: K021-021R, K021-022
- 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:
- Cairn Diagnostics
- Reason for Recall:
- Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Product Codes/Lot Numbers:
Lot Codes: K021-021R, K021-022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1128-2021