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IDS Cortisol
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-4600 · UDI-DI 05060169690691
CGR
Prescription
10
510(k) clearances
7
Adverse events
7
Recalls
18
Facilities
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 of user-specified m |
| 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 between the CC tests, CC |
| 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 rate of calibration fai |
| 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 decreased) by up to 16%). |
| 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 /IMMULITE 1000 (LKCO1) |
| 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 above may produce supp |
| 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 for patient samples du |
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Get your free API keyRead the docsData 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.