Events

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

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Dako North America Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70898
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1548-2015
  • Date de mise en oeuvre de l'événement
    2015-04-01
  • Date de publication de l'événement
    2015-04-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135433
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Slide stainer, automated - Product Code KPA
  • Cause
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • Société-mère du fabricant (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA