Fluorometric, Cortisol
Clinical Chemistry · 21 CFR 862.1205
Recent MDR events
75 adverse event reports on file
- ELECSYS CORTISOL IIJun 24, 2026MalfunctionRoche Diagnostics1823260-2026-02496
- ELECSYS CORTISOL IIJun 22, 2026MalfunctionRoche Diagnostics1823260-2026-02458
- ELECSYS CORTISOL IIMay 11, 2026MalfunctionRoche Diagnostics1823260-2026-01824
- ELECSYS CORTISOL IIMar 25, 2026MalfunctionRoche Diagnostics1823260-2026-01075
- ELECSYS CORTISOL IIJan 12, 2026MalfunctionRoche Diagnostics1823260-2026-00140
- ELECSYS CORTISOL IIDec 22, 2025MalfunctionRoche Diagnostics1823260-2025-05286
- ELECSYS CORTISOL IIDec 16, 2025MalfunctionRoche Diagnostics1823260-2025-05134
- ELECSYS CORTISOL IIDec 15, 2025MalfunctionRoche Diagnostics1823260-2025-05122
- ELECSYS CORTISOL IINov 20, 2025MalfunctionRoche Diagnostics1823260-2025-04742
- ELECSYS CORTISOL IINov 20, 2025MalfunctionRoche Diagnostics1823260-2025-04745
Event type breakdown
Most-reported manufacturers
Recalls
5 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedMay 3, 2023
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the qu
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Z-1504-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedMay 3, 2023
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Num
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Z-1505-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedApr 9, 2012
Siemens ADVIA Centaur Cortisol Assay
Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
Z-1390-2012 · View FDA record ↗ - Abbott Laboratories HPD/ADD/GPRDTerminatedJul 20, 2004
TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
Z-0723-04 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK Cort; Part Number: 025287
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2094-2018 · View FDA record ↗
Registered firms
21 firms currently registered for this product code
Tosoh Aia, Inc.
TOYAMA, JP
Abbott Gmbh
Wiesbaden Hesse, DE
Tosoh Corp.
Chuo-ku Tokyo, JP
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Tosoh Bioscience, Inc.
Grove City, OH, US
Abbott Ireland
SLIGO, IE
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Abbott Laboratories
Lake Forest, IL, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Siemens Healthcare Diagnostics Manufacturing Ltd.
SWORDS Dublin, IE
Siemens Healthcare Diagnostics Inc
East Walpole, MA, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Biomerieux Sa
MARCY L ETOILE Rhone, FR
510(k) clearances
20 clearances for this product code
- Roche DiagnosticsJul 17, 2025
K242505 · Elecsys Cortisol III
- Siemens Healthcare Diagnostics, Inc.Nov 25, 2019
K192788 · ADVIA Centaur Cortisol (COR)
- Roche DiagnosticsApr 27, 2016
K152227 · Elecsys Cortisol II, Cortisol II CalSet
- Siemens Healthcare Diagnostics, Inc.Mar 31, 2015
K142723 · ADVIA Centaur Cortisol (COR) Assy
- Seradyn, Inc.Sep 22, 2006
K062204 · ARCHITECT CORTISOL ASSAY
- Fujirebio Diagnostics,Inc.Feb 20, 2004
K033731 · AXSYM CORTISOL ASSAY
- Roche Diagnostics Corp.Sep 9, 2002
K021218 · ELECSYS CORTISOL TEST SYSTEM
- Ciba Corning Diagnostics Corp.Nov 5, 1996
K962559 · ACS CORTISOL IMMUNOASSAY