Events

Rappel de BD GeneOhm Cdiff Assay

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 Becton Dickinson & Co..

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
    66933
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0790-2014
  • Date de mise en oeuvre de l'événement
    2013-10-11
  • Date de publication de l'événement
    2014-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124243
  • 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
    Reagents, clostridium difficile toxin - Product Code LLH
  • Cause
    An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for clostridium difficile in patient samples.
  • Action
    Becton Dickinson sent an Urgent Product Recall Letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They were advised that a portion of the BD GeneOhm Cdiff assay test kits from one lot, 08T13108, may contain incorrect bags of sample buffer tube. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was discarded. Please fax to 410-316-4258.

Device

BD GeneOhm Cdiff Assay
  • Modèle / numéro de série
    Lot 08T13108 Exp Dec 24 2013
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
  • Description du dispositif
    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** || The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA