Leica Biosystems Recalls Ariol Automated Scanning Microscopes Due to Software Issue
Leica Biosystems Richmond Inc. is recalling 33 Ariol automated scanning microscope systems because a manufacturing error resulted in an improperly activated Windows 7 operating system.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software licensing/activation error rather than a direct safety hazard like malfunction or contamination.
Plain-English summary
Leica Biosystems Richmond Inc. is recalling 33 Ariol automated scanning microscope and image analysis systems. These devices are intended for in vitro diagnostic use to aid pathologists in detecting, classifying, and counting cells, specifically for measuring Estrogen and Progesterone Receptors in breast cancer specimens.
The recall was initiated because an issue during the manufacturing process caused the systems to have an improperly activated Windows 7 operating system, despite a valid license being associated with each unit. The affected systems were distributed to consignees in the United States, China, Japan, Russia, Italy, and England.
Users of the affected Ariol systems should contact Leica Biosystems Richmond Inc. for further instructions regarding the recall and resolution of the software activation issue.
The recalled product
- 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.…
- Manufacturer
- Leica Biosystems Richmond Inc.
- Hazard
- Affected units
- 33
Distribution
Distributed nationwide across the United States.
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