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 a…

Recall date

May 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1948-2016

FDA classification

Class III

Brand / firm

Leica Biosystems Richmond Inc.

Sold / distributed

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

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.