Lower riskMedical device recall · FDA · Published January 8, 2021
Cairn Diagnostics GEBT Test May Give False Negative Gastroparesis Diagnosis
Cairn Diagnostics recalls 13C-Spirulina Gastr: 13C-Spirulina Gastric Emptying Breath Test kits with lot codes K021-021R and K021-022 may cause false negative results for gastroparesis diagnosis.
“Cairn Diagnostics GEBT Test May Give False Negative Gastroparesis Diagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63440-cairn-diagnostics-gebt-test-may-give-false-negative-gastroparesis-diagnosis. Based on FDA recall #Z-1128-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1128-2021%22&limit=1).
Cairn Diagnostics recalled 13C-Spirulina Gastric Emptying Breath Test kits due to the potential for false negative diagnosis of gastroparesis, according to the FDA. The recall was announced on Jan. 8, 2021.
How to tell if you have it
Brand: Cairn Diagnostics
Product: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
Lot Codes: K021-021R, K021-022
Quantity: 103 kits
The hazard
Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates, which can lead to a false negative diagnosis of gastroparesis.
How to tell if you have this one
Check the lot code on the test kit. Affected kits have lot codes K021-021R or K021-022.
Brand
Cairn Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Code
Look for lot codes K021-021R or K021-022 on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Kansas, Michigan, New York, North Carolina.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1128-2021 (January 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1128-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.