ROCHE DIGITAL PATHOLOGY DX /NAVIFY® DIGITAL PATHOLOGY (ON PREM)
Received Apr 29, 2026 · Event occurred Jan 8, 2026
Report 2028492-2026-01688 · MDR key 25032443
Device
Generic name
Whole Slide Imaging System
Manufacturer
Ventana Medical Systems Inc.Catalog number
10092343001
Product problems
- Application Program Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE NAVIFY® DIGITAL PATHOLOGY IS A COMPONENT OF THE ROCHE DIGITAL PATHOLOGY DX. ROCHE DIAGNOSTICS STARTED THE INVESTIGATION AND IDENTIFIED THE ROOT CAUSE. THE ISSUE WAS INTRODUCED IN NAVIFY® DIGITAL PATHOLOGY (NDP) VERSION 2.5, AND SUSTAINED IN VERSIONS 2.5.0.1, 2.5.0.2, AND 2.5.1 WHEN NEW SORTING LOGIC WAS APPLIED TO SPECIMEN LABELS BUT WAS NOT APPLIED TO THE CORRESPONDING WHOLE SLIDE IMAGES IN THE VIEWER WINDOW. WHILE SPECIMEN, BLOCK, AND IMAGE LABELS FOLLOW STRICT ALPHABETICAL ORDERING, WHOLE SLIDE IMAGES ARE SORTED INCONSISTENTLY DUE TO DIFFERENCES IN HOW THE USER INTERFACE SORTS NUMERIC VERSUS TEXT-BASED NAMES. THE MAIN CONTRIBUTING FACTOR IS THE CUSTOMER¿S NAMING CONVENTION FOR SPECIMENS. THE SOFTWARE ITSELF DOES NOT CURRENTLY PROVIDE ANY ERROR FLAG/MESSAGE FOR THIS ISSUE. A NEW SOFTWARE PATCH NDP V2.5.2 WAS RELEASED ON 23-APR-2026 AS A MANDATORY UPDATE TO ADDRESS THIS ISSUE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF THE SLIDE INFORMATION AND THE IMAGES NOT MATCHING IN NAVIFY® DIGITAL PATHOLOGY (NDP). IF A CASE EXISTS WITH A SPECIMEN NAME CONTAINING A NUMERIC VALUE WITH LEADING ZERO(S) (001, 002, ETC.) AND ANOTHER SPECIMEN WITH A NAME CONTAINING 100 OR HIGHER, THE SLIDE POSITION DISPLAYED IN THE NDP VIEWER WILL BE SHIFTED FROM ITS ORIGINAL POSITION. THE SLIDE INFORMATION AND IMAGES MATCH PROPERLY WHEN ACCESSED THROUGH THE NDP > DATA MANAGEMENT SECTION. ONLY THE VIEWER SCREEN DISPLAYS THE IMAGES WITH THE INCORRECT LABEL AND BANNER.
Remedial action
- Recall