QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell

FDA device recall Z-1040-2009 · posted 2009-03-24 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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.

Action taken

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.

Root cause

Software change control

Status

Terminated

Product code

NQN

Quantity affected

5 units

Distribution

Nationwide Distribution -- including states of CA, IL, KS, and NY.

Date initiated

2008-11-06

Date posted

2009-03-24

Date terminated

2011-03-16

Location

Bannockburn, IL

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