Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall QCA and iQCA Software

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall QCA and iQCA Software see related information
Date Initiated by Firm November 06, 2008
Date Posted March 24, 2009
Recall Status1 Terminated 3 on March 16, 2011
Recall Number Z-1040-2009
Recall Event ID 50163
510(K)Number K031363  
Product Classification Digital Analyzer - Product Code NQN
Product QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035.

Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications.
Code Information all software versions 3.7 and above
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
2345 Waukegan Rd
Bannockburn IL 60015-1515
For Additional Information Contact
847-405-6565
Manufacturer Reason
for Recall		 A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
FDA Determined
Cause 2		 Software change control
Action Leica Microsystems sent Medical Device Correction letters dated 11/6/08 to the direct accounts, informing them that all versions 3.7 and above of QCA and iQCA software are not in compliance with the original 510(k) cleared software for scoring of immunohistochemical stains in clinical applications. The QCA/iQCA software is only cleared for Estrogen Receptor staining under clinical applications. The accounts were provided with red warning stickers that state: "WARNING The clinical application of QCA software has been cleared only for the measurement of images from microscopic slides of breast cancer specimens stained for the presence of estrogen (ER) nuclear receptor protein only. Performance characteristics of the product, when used outside of this intended use, have not been established." They were instructed to apply the stickers to any existing manuals and or at each point of use, and to instruct all users about the notification. The accounts were also requested to complete and return the enclosed reply form confirming that the changes have been made.
Quantity in Commerce 5 units
Distribution Nationwide Distribution -- including states of CA, IL, KS, and NY.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NQN and Original Applicant = CELL ANALYSIS, INC.
-
-