Events

Recall of Device Recall PT100/PT Link Waterbath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dako North America 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
    53336
  • Event Risk Class
    Class 2
  • Event Number
    Z-0287-2013
  • Event Initiated Date
    2008-05-01
  • Event Date Posted
    2012-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85291
  • 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
    Bath, flotation, tissue - Product Code IDY
  • Reason
    Dako is recalling the pt link waterbath because of a possible electrical hazard. specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
  • Action
    The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.

Device

Device Recall PT100/PT Link Waterbath
  • Model / Serial
    Catalog #: PT-Module
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AK, CA, CO, CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.
  • Product Description
    PT Link Waterbath, Model#PT100. || Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • Manufacturer Address
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • Manufacturer Parent Company (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA