Date Initiated by Firm |
May 06, 2016 |
Create Date |
June 10, 2016 |
Recall Status1 |
Terminated 3 on December 13, 2017 |
Recall Number |
Z-1948-2016 |
Recall Event ID |
74178 |
510(K)Number |
K043519 K033200 K031715
|
Product Classification |
Microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & - Product Code NQN
|
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. |
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 |
Recalling Firm/ Manufacturer |
Leica Biosystems Richmond Inc. 5205 Route 12 Richmond IL 60071
|
For Additional Information Contact |
Joseph Consoli 815-678-2000 Ext. 6177
|
Manufacturer 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.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
According to the firm a decision to conduct a Field Corrective Actions of the Ariol Image Analysis and Scanning Systems was done out of an abundance of caution. Leica Biosystems Richmond sent Medical device Field Correction notification letters to the customers of the potentially affected product. The initial written communication was sent to the customers via first class USPS on May 6, 2016.
The Medical Device Field Correction letter describes the issues identified with the Ariol Image Analysis and Scanning Systems and the Windows 7 operating system. The letter provided the customer with actions they are required to take which include the following:
1) whether they have a properly activated Windows 7 operating system.
2) If they do not have a properly activated operating system they should to contact Leica Technical Support for additional information and to request a service appointment for correction to their system.
For USA customers, they ask that they call 18005374669.
International customers are asked to go to http://www.leicabiosystems.com/contactus/contactusonline/ and then choose your country.
3) Customers are asked to confirm receipt of the notice by signing and dating the attached Acknowledgement Form and emailing a copy to RichRA@leicamicrosystems.com or faxing it back to us at 18472363800.
Service personnel will be sent to the affected customer locations to replace the hard drives of the affected systems. |
Quantity in Commerce |
33 systems |
Distribution |
U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = NQN and Original Applicant = APPLIED IMAGING CORP.
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