Home / Recalls / Leica Biosystems Richmond Inc. / Z-1948-2016

Z-1948-2016 Class III Terminated

Recalled by Leica Biosystems Richmond Inc. — Richmond, IL

Recall Details

Product Type
Devices
Report Date
June 22, 2016
Initiation Date
May 6, 2016
Termination Date
December 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

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 by Leica Biosystems Richmond Inc.

  • Z-3126-2017 Class II — Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intend (July 14, 2017)
  • Z-3125-2017 Class II — Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intende (July 14, 2017)
  • Z-3123-2017 Class II — Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended f (July 14, 2017)
  • Z-3122-2017 Class II — Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF (July 14, 2017)
  • Z-3121-2017 Class II — Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is inten (July 14, 2017)
  • Z-3120-2017 Class II — Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is i (July 14, 2017)
  • Z-3124-2017 Class II — Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is in (July 14, 2017)
  • Z-2039-2016 Class III — CytoVision Image Analysis and Capture System, an automated cell-locating device. (May 2, 2016)