Leica Biosystems Recalls Three Aperio CS2 CE IVD Scanners
Leica Biosystems is recalling three Aperio CS2 CE IVD scanners due to incorrect sensors that may affect image quality and analysis results.
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, and the source text describes a potential impact on image quality and analysis results without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Leica Biosystems Imaging, Inc. is recalling three Aperio CS2 CE IVD scanner instruments, identified by scanner part number 23CS100CE. The affected units have serial numbers 5899, 5902, and 5986.
The recall was initiated because an incorrect sensor was used during the assembly of the camera in these scanner instruments. This defect can potentially generate whole slide images that impact analysis algorithm results and may also affect the visual appearance of the images.
There was no distribution of these devices in the United States. The units were distributed only to South Korea and the United Kingdom.
The recalled product
- Product
- Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
- Manufacturer
- Leica Biosystems Imaging, Inc.
- Affected units
- 3
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)
- Serial numbers 5899
- 5902
- and 5986.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Leica Biosystems Imaging, Inc.
See all →- ModerateLeica Biosystems Recalls Digital Slide Analysis Software for Breast Cancer Testing
FDA (Devices) · 2014-03-19
Same hazard · defective sensor
See all →- HighDegania Foley Temperature Sensor Catheters Recalled for Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
- HighDegania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
FDA (Devices) · 2018-09-26
Similar recalls
- ModerateLeica Biosystems Recalls Digital Slide Analysis Software for Breast Cancer Testing
FDA (Devices) · 2014-03-19
- HighLuminex ARIES System Recalled for Barcode Scanner Data Error
FDA (Devices) · 2017-05-24
- HighLeica Surgical Microscope Recall Due to Axis Brake Failure
FDA (Devices) · 2013-09-18
- ModerateLeica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination
FDA (Devices) · 2022-10-05
- ModerateAperio ScanScope Systems Recalled for Incorrect User Guide Labeling
FDA (Devices) · 2013-06-26
- HighLuminex Recalls ARIES C. difficile Assay Due to Seal Defects
FDA (Devices) · 2019-08-21