Z-0541-2008

Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ

Name: Z-0541-2008 Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ
Creator: Ventana Medical Systems Inc
Published: 2006-09-29
License: https://open.fda.gov/license/

Ventana Medical Systems Inc / initiated 2006-09-29 / Terminated / root cause: design

FDA source

Ventana Medical Systems Inc began a recall of Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ on 2006-09-29. The reason FDA records is "Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0541-2008
Status: Terminated
Initiated: 2006-09-29
Posted: 2008-01-24
Terminated: 2013-06-06
Recalling firm: Ventana Medical Systems Inc
Product: Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ
Product code: KPA Slide Stainer, Automated
Reason for recall: Leaking Carboys/Safety Updates:The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.
Root cause tag: design
FDA root cause: Device Design
Action: The firm has mailed three customer letters, a) the first letter dated 9/30/2005 describes the upgraded Voila CD that contains safety information; b) a second letter, dated 6/27/2006, identified as a "Customer Alert" was mailed describing an upgrade to the software system version 9.3/10.3 and the CD that includes safety improvements, c) the third letter dated 9/29/2006 and identified as a Safety Alert advises that as part of their effort to continuously improve laboratory safety, they are updating the labeling and instructions for use regarding installation and cleaning for the carboy as the Ventana staining platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed. Enclosed are pictogram labels that indicate "slip hazard" and "refer to instructions for use." The customer is instructed to apply these two labels to the carboys above the spigot as a reminder to laboratory personnel to keep the spigot in the full "off" position when not in use and to refer to the instructions for use for maintenance. In addition, the letter advises that there is an electrical shock warning for the power strip that is part of their system to indicate that it should be mounted off of the floor. This power strip is intended to connect the computer components of the staining system and should not be placed on the floor where fluid might contact it. Also included is a warning label for shock hazard to apply to their power strip.
Quantity in commerce: USA - 1,712 units; Foreign - 1,159 units (total for recalls-Z-0537-0541-2008)
Distribution: Worldwide; USA, Australia, China, Canada, Germany, Great Britain, France, Italy, Hungary, Singapore, Korea, Taiwan, Spain, Poland, Greece, Austria, Sweden, Japan, Israel, Denmark, Turkey, Finland, Saudi Arabia, The Netherlands, Norway, Slovenia, Ireland, and Belgium
Product codes and lots: Serial Numbers: #710000-711288

Product code KPA

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)