28 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
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 Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 8, 2025
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 Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·October 29, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·May 21, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
FDA Enforcement
Class II
·Ongoing·BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.·March 5, 2025
DxC 700 AU, REF: B86444, B86446
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·March 18, 2026
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·May 7, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 9, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·August 28, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Mishima K.K.·August 7, 2024
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Biomedical Division·November 22, 2023
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·October 29, 2025
Radiography 7300 C; Model Number: 712037;
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
ProxiDiagnost N90. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022
CombiDiagnost R90 Software Version R1.0 and R1.1
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022