Leica Biosystems Richmond Inc. recalls Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an ai

Recalled June 22, 2016 · FDA recall Z-1948-2016 · Leica Biosystems Richmond

Hazard

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. · FDA Class III

Units

33 systems

Sold at

U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.

Description

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.

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.

Manufacturer(s)

Leica Biosystems Richmond Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →