Reported Jun 22, 2016 · Terminated
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an…
Leica Biosystems Richmond Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Biosystems Richmond Inc. · 5205 Route 12 · Richmond, IL · 60071
Is this the product you have?
- 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.
- Lot codes and dates
- Serial # System
30013923ADMWS30015723ADMWS30015423ADMR30015323ADMR30015223ADMWS30013323ADMR30013223ADMR30013123ASLOMWS30016023ADMWS30012723AUWS30012823ASlDMWS30015123ADMR30015023ASlDMWS30015523ASLDMWS30015923ASLOMWS30012923ADMR30015623ADMWS30014023ASLDMWS30014923ADMR30014823ADMR30014723AOMR30014623ADMR30014523ADMR30014423ADMR30013023ADMWS30013423ASLDMWS30014223ASLDMWS30013823ASLDMWS30013523ADMWS30013623ASLDMWS
- Serial # System
- Amount recalled
- 33 systems
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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