Recall Z-1948-2016 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Leica Biosystems Richmond Inc.
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 posi
| Date | May 6, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 33 systems |
| Distribution | U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England. |
| FDA record | Open on fda.gov |