11 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
FDA Recall
Open, Classified
·Cell Marque Corporation·Product code NJT·July 15, 2021
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
FDA Recall
Open, Classified
·Leica Microsystems, Inc.·Product code NJT·November 18, 2019
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
FDA Recall
Open, Classified
·Ventana Medical Systems, Inc.·Product code NJT·June 27, 2024
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
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 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
MPOX Test
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code NJT·November 3, 2025
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J 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
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024
Intelli-C, Left side suspended Tabletop, REF: 03400010
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023
Intelli-C, Right side suspended Tabletop, REF: 03400000
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023
1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 BIRKEGAARDSVEJ 16 Hasselager Denmark·Product code OWB·January 21, 2022