Z-0877-2021Class II

uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

Name: Z-0877-2021 uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Creator: Roche Molecular Systems, Inc.
Published: 2020-11-23
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2020-11-23 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 on 2020-11-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0877-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Posted: 2021-01-17
Terminated: 2023-05-22
Recalling firm: Roche Molecular Systems Inc
Product: uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Product code: NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Reason for recall: 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 tag: software
FDA 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 tumor measurements (e.g., melanoma, etc.) be considered for re-review, especially if the original diagnosis included a reported measurement (e.g., Breslow depth in melanoma, etc.). Pathologists need to assess the risk of this measurement error in the context of local pathology reporting processes and clinical decision making. Re-review should be limited to the following conditions, all of which are required for the issue to occur: 1. Slides were viewed in uPath Enterprise software version 1.1, 2. The tumor measurement was done in the Split View viewing mode, and 3. The slides within the Split View viewing mode were scanned at two different magnifications. Only under these conditions is a re-review and repeat tumor measurement recommended.
Quantity in commerce: 27
Distribution: Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
Product codes and lots: version 1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0877-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0877-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-16

Product code NQN

K140465Class IIVirtuoso System for Ihc Er (Sp1) with Benchmark Ultra StainerVentana Medical Systems, Inc. / cleared 2014-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)