ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent handling of the device. The end result may lead to damage or to loss of tissue specimens.

Leica Microsystems sent a Urgent Medical device Recall letter dated March 30, 2012, to all affected customers in the U.S. on the same date. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed of the potential malfunction of the device in the autorotation mode, which could lead to damage or loss of tissue specimens. The letter provided instructions on what the customer should do with the recalled product in the interim before the software fix can be installed. They were instructed to follow the steps below: 1. Remove and dispose all reagents including Paraffin and clean all bottles and Paraffin bathes. 2. Conduct a "Smart Clean" (IFU, chapter 6.1.4). 3. In Submenu "System Setup", here at "Program options", respectively "Station sequence", customer shall switch from "Concentration" to "Auto by RMS". 4. Prestored Xylene protocols shall be used instead of autorotation protocols (IFU, chapter 5.6.2 "Time - optimized Xylene infiltration programs"). Here you find the five validated programs which need to be copied to Favorite programs (IFU, chapter 5.5.3). 5. Use the Reagents, bottle set up from "Time optimized Xylene programs" (IFU, chapter 5.6.2., page 134) and implement them into submenu "Reagents" (IFU, chapter 5.2. following pages). 6. In submenu "The RMS system adjusting warning thresholds rules" (IFU, chapter 5.2.2) the validated reagent thresholds need to be implemented into Submenu "Reagents" (IFU, chapter 5.2). 7. Current Reagent management values are visible within Submenu "Reagent Status" (IFU, chapter 5.2.3) The customers were also informed that their Leica Microsystems representative will them to make the necessary arrangements to complete a software upgrade at no charge. The customers were also requested to sign and date the enclosed acknowledgement form and fax it back to Leica at 847-236-3747 or e-mail it to [email protected] within 10 working da