Radioimmunoassay, Acth
Clinical Chemistry · 21 CFR 862.1025
Recent MDR events
33 adverse event reports on file
- ELECSYS ACTHJan 29, 2026MalfunctionRoche Diagnostics1823260-2026-00314
- ELECSYS ACTHDec 29, 2025MalfunctionRoche Diagnostics1823260-2025-05351
- ELECSYS ACTHAug 7, 2025MalfunctionRoche Diagnostics1823260-2025-02417
- ELECSYS ACTHApr 23, 2025MalfunctionRoche Diagnostics1823260-2025-01248
- ELECSYS ACTHFeb 24, 2025MalfunctionRoche Diagnostics1823260-2025-00528
- ELECSYS ACTHOct 17, 2024MalfunctionRoche Diagnostics1823260-2024-03007
- ELECSYS ACTHOct 4, 2024MalfunctionRoche Diagnostics1823260-2024-02899
- ELECSYS ACTHJun 5, 2024MalfunctionRoche Diagnostics1823260-2024-01677
- ELECSYS ACTHNov 14, 2023MalfunctionRoche Diagnostics1823260-2023-03604
- ELECSYS ACTHSep 21, 2023MalfunctionRoche Diagnostics1823260-2023-03056
Event type breakdown
Recalls
6 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Neurotransmitters Basic
Distribution without premarket approval/clearance.
Z-0789-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Neurotransmitters Plus
Distribution without premarket approval/clearance.
Z-0790-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Neurotransmitters XL
Distribution without premarket approval/clearance.
Z-0791-2026 · View FDA record ↗ - Beckman Coulter Inc.TerminatedAug 20, 2012
UniCel DxH Slidemaker Stainer Instrument System, PN 775222.
The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, exposing sharpt edges on the DxH Slidemaker Stainer Reagent Cabinet (Floor Stand) drawer slides. The sharp edges on the drawer slides may expose operators to physical injury when replacing reagents and waste containers whic
Z-2225-2012 · View FDA record ↗ - Nichols Institute DiagnosticsTerminatedJul 28, 2005
Nichols Advantage ACTH Test System, catalog number 62-7004.
Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
Z-1044-05 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormon
Z-0676-2019 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Tosoh Bioscience, Inc.
Grove City, OH, US
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Diamond Diagnostics Inc.
Budapest, HU
Tosoh Aia, Inc.
TOYAMA, JP
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Immunodiagnostic Systems Ltd.
Boldon Colliery Durham, GB
Laboratorios Scantibodies S.a. De C.v.
TECATE Baja California, MX
Tosoh Corp.
Chuo-ku Tokyo, JP
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Monobind, Inc.
Lake Forest, CA, US
Biomerica
Irvine, CA, US
Drg Instruments Gmbh
MARBURG Hesse, DE
Scantibodies Laboratory, Inc.
SANTEE, CA, US
American Laboratory Products Company
Salem, NH, US
Immunocentrix Corporation
Canoga Park, CA, US
Scientific Supplies & Technology, Inc.
Doral, FL, US
Drg International, Inc.
Springfield, NJ, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
510(k) clearances
30 clearances for this product code
- Immunodiagnostic Systems LimitedAug 18, 2023
K223867 · IDS ACTH II
- Tosoh Bioscience, Inc.Dec 1, 2011
K111335 · ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
- Roche Diagnostics Corp.May 3, 2006
K060585 · ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
- Scantibodies Laboratory, Inc.May 20, 2005
K050748 · ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
- Scantibodies Laboratory, Inc.Jun 3, 2002
K021032 · ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
- Future Diagnostics B.V.Jan 17, 2001
K002638 · FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
- Sangui Biotech, Inc.Aug 19, 1998
K982608 · SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
- Nichols Institute DiagnosticsDec 24, 1996
K962601 · NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE