Events

Rappel de Device Recall Autostainer Link 48, Autostainer Plus, Autostainer, and Autostainer Link Instrument

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
    70558
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1261-2015
  • Date de mise en oeuvre de l'événement
    2015-02-12
  • Date de publication de l'événement
    2015-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134032
  • 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
    A false negative result affecting the diagnosis may occur. a defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the as480, or slide locations 35 and 36 on the as100, s3400, and s3800. affected dates are from 12/2013-08/2014.
  • Action
    The firm, Dako, sent an "Urgent Medical Device Recall Notification" letter dated 2/12/15 to customer on 02/12/15. The firm's letter advised customers to do the following: The firm stated that customers can continue to use the instrument however should take the following actions: - Discontinue to use the HercepTest on slide location 34 - As set forth in Dako's staining protocol, use on-slide positive controls and two drop zones - Watch for any indication of buffer leakage from they syringe assembly. This can be done easily when the tubes are checked for air bubbles in connection with exchange of the buffer bottle - Check for weak staining in regards to HercepTest in slide position 34. Dako's Actions: Dako states that a representative will contact the customers within the next few weeks in order to determine whether the HercepTest has been used for staining slides in position 34. The firm has identified a longer term corrective action plan of installing a drip tray under the stopcock and states that a representative will contact the customer when it is available. Transmission of Notice: The firm requests that customers inform those that need to be aware of the notification and to where the instruments might have been transferred to. The firm states that customers should ensure the organizations maintains awareness of the noticed and recommended steps until the corrective actions have been completed. The firm also asks customers to complete, sign, and return the attached recall form as soon as possible. On 02/23/15 the firm sent out a second notification letter to customers with the following additional recommendations: - Discontinue the use of HercepTest in slide location 34, 35, and 36 depending on the make and model of the instrument In addition the firm recommended that customers pay special attention to any indication that leakage has compromised staining. -When staining using the HercepTest protocols, excess leakage from the sy

Device

Device Recall Autostainer Link 48, Autostainer Plus, Autostainer, and Autostainer Link Instrument
  • Modèle / numéro de série
    992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C  Affected dates: 12/2013-08/2014  Each device is labeled with a unique serial number.  Catalog/Model Number: - AS480 - S3800 - S3400 - AS100
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.
  • Description du dispositif
    Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
  • 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