4 results
·
13ms
·
Sources: EU EUDAMED, US FDA
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 30, 2024
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 19, 2025
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CGR·August 4, 2025
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
FDA Recall
Open, Classified
·B.Braun Medical S.A.S. Celsa Lg Medical 30 avenue des Temps Modernes; Cs 10031 Chasseneuil du Poitou CEDEX France·Product code LJT·July 21, 2025