Z-1040-2009

QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor...

Name: Z-1040-2009 QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor...
Creator: Leica Microsystems, Inc.
Published: 2008-11-06
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2008-11-06 / Terminated / root cause: software

FDA source

Leica Microsystems, Inc. began a recall of QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or... on 2008-11-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1040-2009
Status: Terminated
Initiated: 2008-11-06
Posted: 2009-03-24
Terminated: 2011-03-16
Recalling firm: Leica Microsystems, Inc.
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.
Product code: NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: all software versions 3.7 and above

Product code NQN

K031363Class IIQca (Version 3.1)Cell Analysis, Inc. / cleared 2004-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)