Cairn Diagnostics: Medical Device Recall in 2021 - (Recall #: Z-1128-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 8, 2021

Date Posted: February 24, 2021

Recall Number: Z-1128-2021

Event ID: 87186

Reason for Recall:

Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates

Status: Terminated

Product Quantity: 103 kits

Code Information:

Lot Codes: K021-021R, K021-022

Distribution Pattern:

US Nationwide distribution in the states of GA, NY, MI, CA, KS, NC.

Voluntary or Mandated:

Voluntary: Firm initiated