Events

Recall of Device Recall EnVision FLEX, Mouse, High pH (Link)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dako Denmark A/S.

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
    74608
  • Event Risk Class
    Class 2
  • Event Number
    Z-2330-2016
  • Event Initiated Date
    2016-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148026
  • 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
    Reagent, general purpose - Product Code LDT
  • Reason
    The ph of target retrieval solution in the kit measures 4-5 instead of the correct ph of 9.1.
  • Action
    A recall notification letter dated 7/6/16 was sent to customers to inform them that Dako is recalling EnVision FLEX+ kit because the pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. The letter informs the customers that with a pH of 4-5 instead of pH 9 there could be weak staining, false negative or false positive non-specific staining depending on the antibody used. There is the possibility that this staining could lead to a false result. Customers are to discard the affected product, determine the impact as instructed, and confirmed that they have received replacement kits. Customers are instructed to complete the Device Recall Form and contact local sales representative for any questions regarding the recall notification.

Device

Device Recall EnVision FLEX, Mouse, High pH (Link)
  • Model / Serial
    K8002 Lot no: 10112879 K8004 Lot no: 10111463
  • Distribution
    Worldwide Distribution -- US, Canada, and Colombia.
  • Product Description
    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. || Intended for use in immunohistochemistry together with Autostainer Link Instruments.
  • Manufacturer
    Dako Denmark A/S

Manufacturer

Dako Denmark A/S
  • Manufacturer Address
    Dako Denmark A/S, Produktionsvej 42, Glostrup Denmark
  • Manufacturer Parent Company (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA