Recall Z-0877-2021 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Roche Molecular Systems, Inc.
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
| Date | Nov 23, 2020 |
| Status | Terminated |
| Reason | When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications. |
| Root cause | Software design |
| Action | On November 23, 2020, the firm initiated its recall. The firm distributed Urgent Medical Device Correction letters to affected customers using uPath software version 1.1 IVD. Until uPath Enterprise software version 1.1.1 patch is installed, customers using uPath Enterprise software version 1.1 should not analyze slides with different scan magnifications in Split View. In order to reduce the risk of this issue impacting patient care, customers should follow their local procedures and policies regarding retrospective re-review of cases. In particular, it is recommended that cases involving tumo |
| Quantity | 27 |
| Distribution | Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc., Mar 20, 2014 |