Cairn Diagnostics Recalls 13C-Spirulina Gastric Emptying Breath Test Kits
Cairn Diagnostics is recalling 103 kits of the 13C-Spirulina Gastric Emptying Breath Test due to a potential for false negative diagnoses of gastroparesis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic device) where injury has not yet been reported, but the potential for false negative diagnosis poses a significant clinical risk.
Plain-English summary
Cairn Diagnostics is recalling 103 kits of the 13C-Spirulina Gastric Emptying Breath Test (GEBT). The product is intended for use in measuring the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in symptomatic adult humans.
The recall was initiated because certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates, which creates a potential for false negative diagnosis of gastroparesis. The affected lot codes are K021-021R and K021-022.
The products were distributed nationwide in the states of Georgia, New York, Michigan, California, Kansas, and North Carolina. Consumers and healthcare providers should stop using the affected kits and contact Cairn Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Cairn Diagnostics
- Hazard
- Affected units
- 103
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Codes: K021-021R
- K021-022
Distribution
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