Events

Rappel de Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,

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
    55867
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2025-2010
  • Date de mise en oeuvre de l'événement
    2010-05-19
  • Date de publication de l'événement
    2010-07-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92092
  • 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
    Antigens, febrile, slide and tube, all groups, salmonella spp - Product Code GNC
  • Cause
    In vitro diagnostic reagent to aid in the diagnosis of salmonellosis may exhibit decreased or no reactivity. if proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. if control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
  • Action
    The recalling firm notified customers by fax and e-mail on 05/19/10. The notification advised that the referenced lot number of Salmonella 0 Group A Antigen may exhibit decreased or no reactivity when testing the patient's serum directly for homologous antibodies by either a slide or tube agglutination test to aid in the diagnosis of Salmonellosis. The recalling firm also advised that they would issue replacements for the referenced lot number under Catalog number 240731, which would not be available until approximately July 15, 2010. Consignees were requested to return enclosed response form. Customers with questions about replacements should contact BD customer service at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,
  • Modèle / numéro de série
    Lot 9126057, Exp May 04, 2012
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was sold to distributors nationwide and to affiliates in Belgium and Korea.
  • Description du dispositif
    Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***
  • 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