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Elecsys Cortisol III

Roche Diagnostics GmbH · Model 07682808190 · UDI-DI 07613336180778

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510(k) clearances

Adverse events

Recalls

Facilities

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, depending upon the assay.
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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.