Roche uPath software 1.1 recalled for incorrect measurement calculations
Roche Molecular Systems is recalling uPath software 1.1 because measurement values are incorrectly calculated in Split View mode when slides have different magnifications.
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 classified as FDA Class II. The hazard is a software calculation error that does not involve a physical safety risk like fire or injury, nor is it a high-risk pathogen or allergen issue, fitting the criteria for a moderate severity software defect.
Plain-English summary
Roche Molecular Systems, Inc. is recalling uPath software 1.1 and uPath software 1.1 IVD-INSW, material numbers 08991871001 and 09077332001. The recall involves 27 units distributed domestically to Maryland and Michigan, and internationally to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
The recall is due to a software defect where measurement values are incorrectly calculated when a user creates a measurement tool annotation and views the measurement in "Split View" mode. This error occurs specifically when the slides within the case are scanned at different magnifications.
Users of the affected software should contact Roche Molecular Systems, Inc. for instructions on how to resolve the issue. The source text does not report any illnesses or injuries associated with this software defect.
The recalled product
- Product
- uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
- Manufacturer
- Roche Molecular Systems, Inc.
- Category
- Medical Device — Software
- Affected units
- 27
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 (1)
- version 1.1
Distribution
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