Cairn Diagnostics 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Brand
Cairn Diagnostics
Lot Codes / Batch Numbers
Lot Codes: K021-021R, K021-022
Products Sold
Lot Codes: K021-021R, K021-022
Cairn Diagnostics is recalling 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measureme due to Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Recommended Action
Per FDA guidance
The firm initiated the recall by telephone or email, followed with a telephone call on 01/08/2021. Commercial clients have been instructed not to use GEBT kits and that Cairn will follow up with a recall notice with full instructions on what to do with kits.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026