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Leica Biosystems Imaging Recalls
2 recalls on record · March 19, 2014 to October 16, 2019 · Medical Devices
Recalls by year
14
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 16, 2019Medical DevicesFDA
Leica Biosystems Imaging, Inc. recalls Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Hazard: The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images.
March 19, 2014Medical DevicesFDA
Leica Biosystems Imaging, Inc. recalls HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digit
Hazard: 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