Events

Recall of Benchmark

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventana Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45496
  • Event Risk Class
    Class 2
  • Event Number
    Z-0537-2008
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65645
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated Slide Stainer - Product Code KPA
  • Reason
    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
    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.

Device

Benchmark
  • Model / Serial
    Serial Numbers: #810000-822654
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc, Tucson, AZ
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Manufacturer Address
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755-1962
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    USFDA