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.

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.

According to the firm a decision to conduct a Field Corrective Actions of the Ariol Image Analysis and Scanning Systems was done out of an abundance of caution. Leica Biosystems Richmond sent Medical device Field Correction notification letters to the customers of the potentially affected product. The initial written communication was sent to the customers via first class USPS on May 6, 2016. The Medical Device Field Correction letter describes the issues identified with the Ariol Image Analysis and Scanning Systems and the Windows 7 operating system. The letter provided the customer with actions they are required to take which include the following: 1) whether they have a properly activated Windows 7 operating system. 2) If they do not have a properly activated operating system they should to contact Leica Technical Support for additional information and to request a service appointment for correction to their system. For USA customers, they ask that they call 18005374669. International customers are asked to go to http://www.leicabiosystems.com/contactus/contactusonline/ and then choose your country. 3) Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to [email protected] or faxing it back to us at 18472363800. Service personnel will be sent to the affected customer locations to replace the hard drives of the affected systems.