Reported Feb 24, 2021 · Terminated
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of…
Cairn Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cairn Diagnostics · 105 Westpark Dr Ste 150 · Brentwood, TN · 37027-1012
Is this the product you have?
- 13C-Spirulina Gastric Emptying
- Breath Test (GEBT) - Product Usageintended 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
- Lot codes and dates
- Lot Codes
K021-021RK021-022
- Lot Codes
- Amount recalled
- 103 kits
Where it was sold
Why it was recalled
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
This product could cause temporary or reversible health problems — stop using it.
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