Events

Rappel de Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2

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 Greiner Bio-One 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
    62595
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2154-2012
  • Date de mise en oeuvre de l'événement
    2012-07-02
  • Date de publication de l'événement
    2012-08-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111118
  • 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
    Tubes, vacuum sample, with anticoagulant - Product Code GIM
  • Cause
    Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
  • Action
    Distributors were notified by letter on 07/02/2012 and customers were sent a letter dated 07/05/2012. The letters identified the affected product and the reason for the recall. Distributors were asked to stop distributing the affected product and to complete the attached Product Disposition form. The form along with the affected product was to be returned to GBO. The firm will provide replacement stock or issue a credit once product return and receipt of the Product Disposition form has been confirmed. Customers were also asked to complete the Product Disposition Site Confirmation form and fax it back to Greiner Bio-One North America, Inc. at the number provided. The letter states that the firm will replace any affected product once the form is received. Questions should be directed to 800-515-8112.

Device

Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2
  • Modèle / numéro de série
    Lot #B041206
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, || Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. || Intended Use: Venous blood collection tubes.
  • Manufacturer
    Greiner Bio-One North America, Inc.

Manufacturer

Greiner Bio-One North America, Inc.
  • Adresse du fabricant
    Greiner Bio-One North America, Inc., 4238 Capital Dr, Monroe NC 28110
  • Société-mère du fabricant (2017)
    Greiner Holding Ag
  • Source
    USFDA