Ariol is an automated scanning microscope and image analysis system — Class III medical device recall Z-1948-2016
Terminated recall by Leica Biosystems Richmond Inc., reported 2016-06-22, distributed nationwide. An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even th
| Recall number | Z-1948-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Biosystems Richmond Inc., Richmond, IL, United States |
| Recall initiated | 2016-05-06 |
| Classified | 2016-06-10 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, GB, IT, JP, RU |
| Quantity | 33 systems |
Product
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
Reason for recall
An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1948-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.