Leica Biosystems Recalls Digital Slide Analysis Software for Breast Cancer Testing
Leica Biosystems is recalling 78 units of the ScanScope System software to clarify usage with specific RUO products.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is described as being conducted 'in an abundance of caution' to clarify usage, which aligns with the rubric for voluntary precautionary recalls and minor labeling or usage errors.
Plain-English summary
Leica Biosystems Imaging, Inc. is recalling 78 units of the ScanScope System, an automated digital slide creation and analysis system intended for in vitro diagnostic use. The recall involves specific software applications including HER2 Image Analysis, Manual Read of HER2 Digital Slides, and ER/PR Image Analysis. These tools are used by pathologists to aid in the detection and measurement of HER2/neu and ER/PR receptors in breast cancer tissue samples.
The recall is being conducted in an abundance of caution to provide additional information clarifying the use of these digital image analysis applications with specific Research Use Only (RUO) products identified in an earlier notification. The affected units were distributed in the United States, including the states of Florida, Washington, Pennsylvania, Mississippi, Texas, Minnesota, California, New York, New Jersey, North Carolina, Colorado, and Ohio.
Healthcare facilities and laboratories that possess these specific software applications should contact Leica Biosystems for further instructions on how to proceed. The recall is intended to ensure that the software is used correctly in conjunction with the appropriate reagents and to prevent potential misinterpretation of diagnostic results.
The recalled product
- Product
- 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…
- Manufacturer
- Leica Biosystems Imaging, Inc.
- Hazard
- Affected units
- 78
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 23elHCKIT2500
- 23elHCKIT5000
- 23elHCKIT500.
Distribution
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