Events

Recall of Device Recall ultraView Universal DAB Detection Kit

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
    58855
  • Event Risk Class
    Class 2
  • Event Number
    Z-2716-2011
  • Event Initiated Date
    2011-05-16
  • Event Date Posted
    2011-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100422
  • 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
    Immunohistochemistry antibody assay, estrogen receptor - Product Code MYA
  • Reason
    The recall was initiated because ventana medical systems, inc. (ventana), has identified the presence of precipitate in some dab chromogen dispensers in two lots of ultraview universal dab detection kit (part number 760-500, lot a05885 and lot b00988) and one lot of iview dab detection kit (part number 760-091, lot b01057a.).
  • Action
    The firm, Ventana, sent two letters dated May 16, 2011, an "URGENT Medical Device Recall" notice to customers who received the affected lots and an "URGENT Medical Device Correction" to customers of unaffected lots. The letters described the product, problem and actions to be taken. The customers were instructed to discontinue use of any kits from the lots identified above; follow their internal standard operating procedures for assessing potential impact to reported patient results, If their laboratory had already used kits from these lots; conduct visual inspections of any DAB chromogen dispensers in use as part of their daily maintenance routine; inspect their current inventory and contact their local customer support team (800-227-2155) to replace any unused or partially used kits from the affected lots. Ventana highly recommends use of same-slide controls, especially when testing for targets of therapy, to mitigate any impact on patient results. If you find a dispenser containing precipitate in lots not identified in this letter or have any questions and concerns, please notify/contact your local customer support team (800-227-2155) .

Device

Device Recall ultraView Universal DAB Detection Kit
  • Model / Serial
    Lot number: A05885 & B00988
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of Canada, Germany and Israel.
  • Product Description
    ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) || This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies. The kit is intended for laboratory use to identify targets by immunohistochemistry (IHC) in sections of formalin fixed, paraffin embedded and frozen tissue on Ventana Medical Systems (Ventana) automated slide stainers by light microscopy. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests.
  • 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