13C-Spirulina Gastric Emptying Breath Test — Class II medical device recall Z-1128-2021
Terminated recall by Cairn Diagnostics, reported 2021-02-24, distributed nationwide. Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unu
| Recall number | Z-1128-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cairn Diagnostics, Brentwood, TN, United States |
| Recall initiated | 2021-01-08 |
| Classified | 2021-02-16 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 103 kits |
| Lot numbers | 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 as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Reason for recall
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1128-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.