Z-1128-2021Class II

13C-Spirulina Gastric Emptying Breath Test (GEBT) -

Name: Z-1128-2021 13C-Spirulina Gastric Emptying Breath Test (GEBT) -
Creator: Cairn Diagnostics
Published: 2021-01-08
License: https://open.fda.gov/license/

Cairn Diagnostics / initiated 2021-01-08 / Terminated

FDA source

Cairn Diagnostics began a recall of 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... on 2021-01-08. FDA classified it as Class II and gives the reason as "Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1128-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-08
Posted: 2021-02-16
Terminated: 2023-08-09
Recalling firm: Cairn Diagnostics
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.
Product code: PGE Gastric Emptying Breath Test
Reason for recall: Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 103 kits
Distribution: US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.
Product codes and lots: Lot Codes: K021-021R, K021-022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1128-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1128-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-16

Product code PGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)