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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery XT

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 Class 2 Device Recall Discovery XTsee related information
Date Initiated by FirmSeptember 29, 2006
Date PostedJanuary 24, 2008
Recall Status1 Terminated 3 on June 06, 2013
Recall NumberZ-0541-2008
Recall Event ID 45496
Product Classification Automated Slide Stainer - Product Code KPA
ProductDiscovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Ventana Medical Systems Inc, Tucson, AZ
Code Information Serial Numbers: #710000-711288
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85755-1962
For Additional Information ContactAnita Wample
520-229-3928
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe 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 CommerceUSA - 1,712 units; Foreign - 1,159 units (total for recalls-Z-0537-0541-2008)
DistributionWorldwide; 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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