Radioimmunoassay, Calcitonin
Clinical Chemistry · 21 CFR 862.1140
Recent MDR events
37 adverse event reports on file
- ELECSYS CALCITONINMar 25, 2026MalfunctionRoche Diagnostics1823260-2026-01087
- ELECSYS CALCITONINOct 16, 2025MalfunctionRoche Diagnostics1823260-2025-04207
- IMMULITE 2000 CALCITONINNov 26, 2024MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2024-00473
- IMMULITE 2000 CALCITONINMay 17, 2024MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2024-00319
- IMMULITE 2000 XPI CALCITONIN (CAL)Sep 9, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2022-00279
- IMMULITE 2000 XPI CALCITONINApr 5, 2022MalfunctionSiemens Healthcare Diagnostics Privated Limited1219913-2022-00097
- IMMULITE 2000 XPI CALCITONINApr 5, 2022MalfunctionSiemens Healthcare Diagnostics Private Limited1219913-2022-00095
- ELECSYS CALCITONINDec 28, 2021MalfunctionRoche Diagnostics1823260-2021-03885
- ELECSYS CALCITONINDec 28, 2021MalfunctionRoche Diagnostics1823260-2021-03886
- IMMULITE 2000 CALCITONINNov 19, 2021MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2021-00492
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
13 firms currently registered for this product code
Diasorin Inc.
Stillwater, MN, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Axis-shield Diagnostics, Ltd.
DUNDEE Scotland, GB
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Drg International, Inc.
Springfield, NJ, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
American Laboratory Products Company
Salem, NH, US
Monobind, Inc.
Lake Forest, CA, US
Biomerica
Irvine, CA, US
510(k) clearances
20 clearances for this product code
- Roche Diagnostics GmbHApr 24, 2026
K252431 · Elecsys Calcitonin
- Axis-Shield Diagnostics LimitedDec 21, 2018
K182012 · ADVIA Centaur Calcitonin (CALCT) assay
- Roche DiagnosticsDec 4, 2013
K132828 · ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
- Scantibodies Laboratory, Inc.Aug 30, 2006
K060578 · CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- Diagnostic Products Corp.Dec 9, 2002
K023304 · IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
- Kmi Diagnostics, Inc.May 11, 1999
K990073 · CALCITONIN
- Sangui Biotech, Inc.Sep 3, 1998
K982491 · SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
- Nichols Institute DiagnosticsMay 21, 1997
K964635 · NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT