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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial # System 300139 23ADMWS 300157 23ADMWS 300154 23ADMR 300153 23ADMR 300152 23ADMWS 300133 23ADMR 300132 23ADMR 300131 23ASLOMWS 300160 23ADMWS 300127 23AUWS 300128 23ASlDMWS 300151 23ADMR 300150 23ASlDMWS 300155 23ASLDMWS 300159 23ASLOMWS 300129 23ADMR 300156 23ADMWS 300140 23ASLDMWS 300149 23ADMR 300148 23ADMR 300147 23AOMR 300146 23ADMR 300145 23ADMR 300144 23ADMR 300130 23ADMWS 300134 23ASLDMWS 300142 23ASLDMWS 300138 23ASLDMWS 300135 23ADMWS 300136 23ASLDMWS
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Leica Biosystems Richmond Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Serial # System 300139 23ADMWS 300157 23ADMWS 300154 23ADMR 300153 23ADMR 300152 23ADMWS 300133 23ADMR 300132 23ADMR 300131 23ASLOMWS 300160 23ADMWS 300127 23AUWS 300128 23ASlDMWS 300151 23ADMR 300150 23ASlDMWS 300155 23ASLDMWS 300159 23ASLOMWS 300129 23ADMR 300156 23ADMWS 300140 23ASLDMWS 300149 23ADMR 300148 23ADMR 300147 23AOMR 300146 23ADMR 300145 23ADMR 300144 23ADMR 300130 23ADMWS 300134 23ASLDMWS 300142 23ASLDMWS 300138 23ASLDMWS 300135 23ADMWS 300136 23ASLDMWS
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1948-2016
Related Recalls
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.