Events

Recall of Discovery Ultra Advanced Staining System Research Use Only (RUO)

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
    64244
  • Event Risk Class
    Class 2
  • Event Number
    Z-0834-2013
  • Event Date Posted
    2013-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115667
  • 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
    Slide stainer, automated - Product Code KPA
  • Reason
    Potential for a waste fluid overflow condition to accur while running decontamination cycles on the benchmark ultra automated staining platform or the discovery ultra automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. this type of overflow event can lead to migration of flu.
  • Action
    The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.

Device

Discovery Ultra Advanced Staining System Research Use Only (RUO)
  • Model / Serial
    Cat#750-601; PN 05987750001; Serial #'s: 310646, 311573, 310477, 311725, 311042, 311623, 312032, 312159, 310615, 310837, 311862, 311043 311572, 311766, 310526, 311011, 311185, 311723, 312082, 310635, 311574, 312084, 310636, 310835, 311179, 310493, 311183, 311769, 311930, 311962, 311963, 310437, 311965, 310997, 311726, 311620, 311512, 311526, 312083, 310468, 310759 (All serial numbers in the market).
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Germany.
  • Product Description
    VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only || Product Usage: || Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

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