143 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
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¿¿ 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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014
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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014
ADVIA Centaur HBc IgM
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LOM·January 2, 2018
ADVIA Centaur¿ HBc IgM
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 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
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 Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics, Inc.·November 24, 2021
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 ¿ Gastrin
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 CEA
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 TG
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018