13C-Spirulina Gastric Emptying Breath Test recall
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and…
Why was 13C-Spirulina Gastric Emptying Breath Test recalled?
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes: K021-021R, K021-022
- Product
- 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and…
- Recalling firm
- Cairn Diagnostics
- Quantity
- 103 kits
- Distribution
- US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
- Recall date
- February 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)