Z-1473-2012

ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH...

Name: Z-1473-2012 ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH...
Creator: Leica Microsystems, Inc.
Published: 2012-03-30
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2012-03-30 / Terminated / root cause: software

FDA source

Leica Microsystems, Inc. began a recall of ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany... on 2012-03-30. The reason FDA records is "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". 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-1473-2012
Status: Terminated
Initiated: 2012-03-30
Posted: 2012-04-27
Terminated: 2012-10-10
Recalling firm: Leica Microsystems, Inc.
Product: 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.
Product code: IEO Processor, Tissue, Automated
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 27 units - U.S., 40 units - ROW
Distribution: Worldwide Distribution -- USA (nationwide) including states of: California, Florida, Georgia, Kentucky, Massachusetts, Minnesota, Mississippi, Nebraska, New York, North Carolina, the District of Columbia; and countries of: Australia, Belgium, France, Germany, China/Hong Kong, Italy, Japan, the Netherlands, Singapore, Switzerland, Turkey and United Kingdom.
Product codes and lots: Model ASP6025, serial numbers 162, 163, 168, 169, 170, 171, 182, 183, 184, 200 through 267

Product code IEO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)