Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Ariol is an automated scanning microscope and image analysis system. Recalled by Leica Biosystems Richmond Inc. Due to An issue during the manufacturing process caused systems...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Leica Biosystems Richmond Inc. directly.
Affected Products
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.
Quantity: 33 systems
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Leica Biosystems Richmond Inc.
Leica Biosystems Richmond Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report