151 results
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Sources: EU EUDAMED, US FDA
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Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·April 5, 2016
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·April 5, 2016
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.
FDA Recall
Terminated
·Biogenex Laboratories·Product code NJT·October 3, 2006
Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA
FDA Recall
Terminated
·Biogenex Laboratories·Product code NJT·September 5, 2006
Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.
FDA Recall
Terminated
·Cell Marque Corporation·Product code NJT·July 12, 2011
UltraVision Plus Detection System; Anti-Polyvalent, Alk-Phos/Fast Red (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
FDA Recall
Terminated
·Lab Vision Corporation·Product code NJT·January 11, 2012
UltraVision Detection System; Anti-Polyvalent, Alk-Phos/BCIP/NBT (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
FDA Recall
Terminated
·Lab Vision Corporation·Product code NJT·January 11, 2012
BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells.
FDA Recall
Terminated
·Biocare Medical Llc·Product code NJT·March 13, 2012
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. This detection system is for in vitro diagnostic use. Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-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. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance, laboratories should stain each patient sample in conjunction with positive, negative and other tissue specific controls as needed.
FDA Recall
Terminated
·Leica Biosystems Newcastle Ltd. Balliol Business Park West, Benton Lane Newcastle Upon Tyne United Kingdom·Product code NJT·July 31, 2013
Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods
FDA Recall
Terminated
·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·March 22, 2016
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
FDA Recall
Terminated
·Lab Vision Corporation·Product code NJT·January 18, 2016
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·December 30, 2015
iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·August 2, 2018
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·July 30, 2021
EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4002
FDA Recall
Terminated
·Dakocytomation California Inc·Product code NJT·October 14, 2005
EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006
FDA Recall
Terminated
·Dakocytomation California Inc·Product code NJT·October 14, 2005