Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Recalled by Leica Biosystems Imaging, Inc. Due to In an abundance of caution, Aperio (now known...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Leica Biosystems Imaging, Inc. directly.
Affected Products
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 (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest" to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. When used with the Dako HercepTest", it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN¿¿(Trastuzumab) treatment is being considered. Note: The IHC HER2 Image Analysis application is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER-2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Dako HercepTest" to assure the validity of the IHC HER2 Image Analysis application assisted HER-2/neu score. The actual correlation of the Dako HercepTest" to Herceptin¿¿ clinical outcome has not been established. Manual Read of HER2 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 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer. The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTestT to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestT, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN¿¿ (Trastuzumab) treatment is being considered. Note: The actual correlation of the Dako HercepTestT to Herceptin¿¿ clinical outcome has not been established. ER/PR Image Analysis: The ScanScope¿¿ XT 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 ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neo
Quantity: 78
Why Was This Recalled?
In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i
Where Was This Sold?
This product was distributed to 12 states: CA, CO, FL, MN, MS, NJ, NY, NC, OH, PA, TX, WA
About Leica Biosystems Imaging, Inc.
Leica Biosystems Imaging, Inc. has 2 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report