29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·December 24, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 10, 2024
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 17, 2024
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 17, 2024
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 17, 2024
Alinity ci-series System Control Module, REF: 03R70-01
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·January 3, 2024
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 3, 2022
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·September 7, 2022
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 3, 2022
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 3, 2022
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·December 1, 2021
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 13, 2022
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·December 1, 2021
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 11, 2021
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·August 11, 2021