Recall Z-1948-2016— Leica Biosystems Richmond Inc.

Name: FDA recall Z-1948-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-06

Class III · Terminated

Class III FDA medical device recall by Leica Biosystems Richmond Inc., initiated 2016-05-06, terminated 2017-12-13. It names 3 FDA 510(k) clearances: K043519, K033200, K031715. 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. 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: 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..

Recalling firm: Leica Biosystems Richmond Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-05-06
Terminated: 2017-12-13
Firm location: Richmond, IL, United States

510(k) clearances named in this recall

3 on FDA's record

K043519 — ARIOL HER-2/NEU FISHApplied Imaging Corp.·cleared 2005-04-25
K033200 — ARIOLApplied Imaging Corp.·cleared 2004-03-18
K031715 — ARIOL HER-2/NEU IHCApplied Imaging Corp.·cleared 2004-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.