Calprotectin, Fecal
Immunology · 21 CFR 866.5180
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
IBS Test
Distribution without premarket approval/clearance.
Z-0784-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Leaky Gut Test
Distribution without premarket approval/clearance.
Z-0787-2026 · View FDA record ↗ - Diasorin Inc.Open, ClassifiedDec 12, 2024
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
Z-0677-2025 · View FDA record ↗
Registered firms
23 firms currently registered for this product code
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Diasorin Inc.
Stillwater, MN, US
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
American Laboratory Products Company
Salem, NH, US
Buhlmann Laboratories Ag
SCHONENBUCH/BASEL Basel-Landschaft, CH
Eurospital S.p.a.
TRIESTE, IT
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Acro Biotech Inc.
Montclair, CA, US
Roche Diabetes Care Gmbh
Mannheim Baden-Wurttemberg, DE
Diazyme Laboratories, Inc.
POWAY, CA, US
510(k) clearances
15 clearances for this product code
- Bühlmann Laboratories AGFeb 6, 2024
K232057 · BÜHLMANN fCAL® turbo and CALEX® Cap
- ALPCOApr 13, 2023
K220763 · ALPCO Calprotectin Immunoturbidimetric Assay
- DiaSorin, Inc.Jul 26, 2022
K213858 · LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
- ALPCOOct 25, 2019
K191807 · ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
- Buhlmann Laboratories AGSep 24, 2019
K191718 · Buhlmann fCAL turbo and CALEX Cap
- Eurospital S.P.A.Jul 10, 2019
K191589 · Calprest, EasyCal
- Eurospital S.P.A.Jul 10, 2019
K191592 · CalprestNG, EasyCal
- Buhlmann Laboratories AGJun 25, 2019
K190784 · BUHLMANN fCAL turbo