Events

Recall of Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module

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
    70898
  • Event Risk Class
    Class 2
  • Event Number
    Z-1548-2015
  • Event Initiated Date
    2015-04-01
  • Event Date Posted
    2015-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135433
  • 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
    If a user requests slides from the lis or tpid, then updates a request by changing the test, the trd software will reject the update. the lis and printed slide label will display the updated test with the requested change, but the omnis system will execute the initial test, not reflecting the change. the system will not warn the user that the test request was rejected.
  • Action
    Dako sent a Voluntary Product Recall Notification letter starting the week of April 1, 2015 along with a acknowledgement attachment. The letter identified the affected product, problem and actions to be taken. The firm requests that customers inform those in their organization of the notification including organizations where the potentially affected instruments have been transferred. The firm requests that customers complete, sign, and return the acknowledgement form within one week after receiving the notification. For questions contact your Dako sales representative. On 04/29/15 the firm sent out an updated customer notification letter in order to provide additional clarification and instructions to customers in regards to the recall situation.

Device

Test Request Distributor (TRD) 1.3 and 1.4 of Dakos OMNIs System software module
  • Model / Serial
    N/A  Serial Number: 1311004352, 1308004862, 1307000537, 1405002266, 1410008844, 1307006995, 1311001075, 1402002186, 1401010308, 1402005995, 1306001697, 1311007317, 1410004066, 1404006200, 1410004067, 1405002263, 1404007225, 1410002144, 1311007321, 1404004226, 1401005960, 1305006010, 1401000919, 1405000371, 1401005963, 1403005465, 1304008205, 1401003711, 1401001048, 1310010425, 1401003715, 1311004354, 1311004355
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S Nationwide in the states of IN and PA and the countries of: Spain, Belgium, France, Netherlands, Denmark, Finland, Sweden, Germany, UK, and Korea.
  • Product Description
    Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. || The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual entries to connected Dako systems.
  • 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