Recall Z-1040-2009 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Leica Microsystems, Inc.
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 u
| Date | Mar 24, 2009 (initiated Nov 6, 2008) |
| Status | Terminated |
| Reason | 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 | 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 brea |
| Quantity | 5 units |
| Distribution | Nationwide Distribution -- including states of CA, IL, KS, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031363 | QCA (VERSION 3.1) Cell Analysis, Inc., Feb 5, 2004 |