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Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro ...

FDA Device Recall #Z-1948-2016 — Class III — May 6, 2016

Recall Summary

Recall Number Z-1948-2016
Classification Class III — Low risk
Date Initiated May 6, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leica Biosystems Richmond Inc.
Location Richmond, IL
Product Type Devices
Quantity 33 systems

Product 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.

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.

Distribution Pattern

U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.

Lot / Code Information

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

Other Recalls from Leica Biosystems Richmond Inc.

Recall # Classification Product Date
Z-3125-2017 Class II Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA08... Jul 14, 2017
Z-3121-2017 Class II Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF P... Jul 14, 2017
Z-3120-2017 Class II Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF ... Jul 14, 2017
Z-3124-2017 Class II Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF ... Jul 14, 2017
Z-3126-2017 Class II Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0... Jul 14, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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