Home › Device types › JFT
Fluorometric, Cortisol
FDA product code JFT · Class 2 · Clinical Chemistry
21
Registered devices
75
Adverse events
5
Recalls
20
510(k) clearances
Devices with this code
Alinity — Abbott Ireland DiagnosticsAtellica Cort Urine Recon Buffer — Siemens Healthcare Diagnostics Inc.Atellica IM Cor MCM — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® COR +E — Siemens Healthcare Diagnostics Inc.Alinity — Abbott Ireland DiagnosticsVIDAS® Serum Free — BIOMERIEUX SAElecsys Cortisol III — Roche Diagnostics GmbHARCHITECT — Abbott Ireland DiagnosticsST AIA-PACK CORT — TOSOH CORPORATIONARCHITECT — Abbott Ireland DiagnosticsAtellica IM Cor — Siemens Healthcare Diagnostics Inc.AIA-PACK CORT Calibrator Set — TOSOH CORPORATIONARCHITECT — Abbott Ireland DiagnosticsAtellica IM Cor — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® COR — Siemens Healthcare Diagnostics Inc.Elecsys Cortisol II — Roche Diagnostics GmbHADVIA Centaur® COR +E — Siemens Healthcare Diagnostics Inc.AIA-PACK CORT Sample Diluting Solution — TOSOH CORPORATIONElecsys Cortisol II — Roche Diagnostics GmbHAtellica IM Cor — Siemens Healthcare Diagnostics Inc.ADVIA Centaur Cortisol Urine Reconstitution Buffer — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-16 | Siemens Healthcare Diagnostics, Inc. | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| 2023-03-16 | Siemens Healthcare Diagnostics, Inc. | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2012-03-06 | Siemens Healthcare Diagnostics, Inc | Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims |
| 2004-02-16 | Abbott Laboratories HPD/ADD/GPRD | The package inserts contain incorrect control values for the urinary free cortisol extraction procedure. |
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