9 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
FDA Recall
Open, Classified
·Hologic Inc·Product code KGI·June 13, 2024
Accure Laser System, Model: PFMS00004
FDA Recall
Open, Classified
·Accure Acne, Inc·Product code GEX·December 6, 2023
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Recall
Open, Classified
·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
FDA Recall
Open, Classified
·Ortho Clinical Diagnostics Inc·Product code CGN·July 12, 2018
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code DCN·March 11, 2025
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024