45 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Ringed DxI Reaction Vessels (RVs)
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 2, 2023
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·October 18, 2023
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 21, 2024
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·July 10, 2024
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 30, 2025
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·February 14, 2024
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 26, 2025
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·September 11, 2024
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·December 18, 2024
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·September 4, 2024
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 26, 2025
DxI 9000 Access Immunoassay Analyzer C11137
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·July 2, 2025
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·October 29, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 19, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·September 25, 2024
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025