Recall Z-1152-2014 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
Leica Biosystems Imaging, Inc.
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 b
| Date | Mar 7, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling False and Misleading |
| Action | Aperio (now known as Leica Biosystems) sent an recall notification letter on February 7, 2014, via USPS mail. The letter dated January 31, 2014, informed customers of the reason for the notification, product description, provided 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 is also for Research Use Only and not for use in d |
| Quantity | 78 |
| Distribution | US Distribution including the states of FL, WA, PA, MS, TX, MN CA, NY, NJ, NC, CO and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.