Events

Rappel de Pacific Hemostasis ThromboplastinDS

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 Fisher Diagnostics, A Company of Fisher Scientific LLC.

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
    57107
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1519-2011
  • Date de mise en oeuvre de l'événement
    2010-10-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95403
  • 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
    Test, time, prothrombin - Product Code GJS
  • Cause
    An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.
  • Action
    The firm, ThermoFisher Scientific, sent two "Urgent Medical Device Removal" letters one via Federal Express on October 20, 2010 and certified mail for domestic customers on October 21, 2010. The letters described the product, problem and action to be taken by the customers. The customers were instructed to indicate the quantities of all affected product currently in stock at their facility; complete and return the attached Response Form/table to Fisher Diagnostics via fax to (540) 869-8129 or by mail to the attention of Technical Support; dispose of any remaining inventory of the affected lot numbers; provide a copy of this letter to their customers, and file this letter for future reference. If you have any questions regarding this notification, please contact our Technical Support staff at 800-528-0494, Option 2, or email techsupport.diagnostics.mtn@themofisher.com.

Device

Pacific Hemostasis ThromboplastinDS
  • Modèle / numéro de série
    V40526, exp 4/2013 V40826, exp 4/2013
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: Alaska, Florida, Kentucky, Ohio, New Jersey, New York, and Texas; and countries including: Argentina, Dubai, Italy, Mexico, Philippines, Romania, and Turkey.
  • Description du dispositif
    Pacific Hemostasis ¿ Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** || Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.
  • Manufacturer
    Fisher Diagnostics, A Company of Fisher Scientific LLC

Manufacturer

Fisher Diagnostics, A Company of Fisher Scientific LLC
  • Adresse du fabricant
    Fisher Diagnostics, A Company of Fisher Scientific LLC, 8365 Valley Pike, Middletown VA 22645-1905
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA