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

FDA device recall Z-0541-2008 · posted 2008-01-24 · Terminated

Recall details

Recalling firm

Ventana Medical Systems Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KPA

Quantity affected

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, Sau

Date initiated

2006-09-29

Date posted

2008-01-24

Date terminated

2013-06-06

Location

Tucson, AZ