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Sources: EU EUDAMED, US FDA
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ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LOM·September 15, 2014
ADVIA Centaur HBc IgM
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code LOM·September 15, 2014
Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KHO·September 29, 2005
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
FDA Recall
Terminated
·Ortho-Clinical Diagnostics, Inc.·Product code JJX·October 15, 2021
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018
Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.
FDA Recall
Terminated
·Bio-Rad Laboratories·January 7, 2008
cobas e801 Immunoassay Analyzer
FDA Recall
Open, Classified
·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LOM·September 5, 2007
IMMULITE /IMMULITE 1000 CEA
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018
IMMULITE /IMMULITE 1000 Vitamin B12
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CDD·January 2, 2018
IMMULITE /IMMULITE 1000 BR-MA (CA15-3)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MOI·January 2, 2018
ADVIA Centaur Folate (FOL)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018
IMMULITE 2000/IMMULITE 2000 XPi Gastrin
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGC·January 2, 2018
IMMULITE 2000/IMMULITE 2000 XPi Folic Acid
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018
IMMULITE 2000/IMMULITE 2000 XPi CEA
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018
Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MMI·January 2, 2018
IMMULITE /IMMULITE 1000 Gastrin
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CGC·January 2, 2018
IMMULITE /IMMULITE 1000 TG
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code MSW·January 2, 2018
IMMULITE /IMMULITE 1000 OM-MA (CA125)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTK·January 2, 2018