Home › Device types › CGR
Radioimmunoassay, Cortisol
FDA product code CGR · Class 2 · Clinical Chemistry
18
Registered devices
7
Adverse events
7
Recalls
84
510(k) clearances
Devices with this code
IMMULITE 2000 Cortisol Kit Domestic 200T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCortisol AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.AccuDiag ™ — Diagnostic Automation, Inc.IMMULITE 2000 Crotisol Kit Domestic 600T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIDS Cortisol — IMMUNODIAGNOSTIC SYSTEMS LIMITEDMonobind AccuLite Cortisol CLIA Kit - 192 Wells — MONOBIND, INC.Cortisol AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Cortisol CT 1000 Tube Kit — MP BIOMEDICALS, LLCCorti-Cote 125I RIA Kit — MP BIOMEDICALS, LLCIMMULITE®/IMMULITE® 1000 Systems COR Cortisol Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDVITROS — ORTHO CLINICAL DIAGNOSTICSAccess Cortisol — Beckman Coulter, Inc.ImmuChem Cortisol Coated Tube 125I RIA Kit — MP BIOMEDICALS, LLCCortisol AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.IMMULITE® 2000 Systems COR Cortisol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE® 1000 Systems COR Cortisol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems COR Cortisol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCortisol CT 500 Tube Kit — MP BIOMEDICALS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-19 | Beckman Coulter, Inc. | Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application |
| 2025-08-04 | Beckman Coulter Inc. | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed betwe |
| 2024-09-30 | Beckman Coulter, Inc. | The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rat |
| 2018-09-18 | Beckman Coulter Inc. | Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decrea |
| 2014-09-19 | Siemens Healthcare Diagnostics | Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IM |
| 2010-02-17 | Beckman Coulter Inc. | The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified ab |
| 2009-07-20 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values fo |
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