Siemens Healthcare Diagnostics, Inc - Atellica IM HER2/neu (H2n) assay and calibrator. ADVIA Centaur HER2/neu (H2n) assay and calibrator - Class 2 Recall
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems H...
Source: Medical Device Recalls - October 17, 2020 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Her2/Neu (EP3) - Class 2 Recall
Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Cell Marque Corporation - Her2/Neu (cerbB2) (CB11) - Class 2 Recall
Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2017 Category: Medical Devices Source Type: alerts
Dako North America Inc. - Dako HER2 CISH pharmDx Kit - Class 2 Recall
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. ...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts
Biogenex Laboratories, Inc. - InSite HER2/neu Detection Kit - Class 2 Recall
Insite HER-2: Detection Kit a semi-quantitative immunohistochemistry assay used to determine the overexpression of c-erbB-2 oncoprotein in patient breast cancer specimens. HRP/DAB Contents: 1 vial Power Block 1 Vial DAB Substrate Buffer 1 Vial DAB Chromogen 1 Vial Super Enhancer Reagent 1 Vial Her-2neu Antibody 1 Vial Poly-HRP Reagent 1 Vial Peroxide Block 1 Vial Hematoxylin 1 Vial Rabbit Negative Control 5 Positive control slides BioGenex, Fremont, CA 94538 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 25, 2014 Category: Medical Equipment Source Type: alerts
Leica Biosystems Imaging, Inc. - ScanScope System - Class 2 Recall
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu...
Source: Medical Device Recalls - March 8, 2014 Category: Medical Equipment Source Type: alerts
Dako North America Inc. - Dako HER2 CISH pharmDx(tm) kit - Class 2 Recall
Product Name: HER2 CISH pharmDx" Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated...
Source: Medical Device Recalls - February 27, 2014 Category: Medical Equipment Source Type: alerts
