FDA recall Z-1128-2021

Cairn Diagnostics · Class II · device

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-01-08
Report date
2021-02-24
Termination date
2023-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brentwood, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1128-2021