Events

Rappel de Xpert CT/NG

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 Cepheid.

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
    78910
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0592-2018
  • Date de mise en oeuvre de l'événement
    2017-10-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160839
  • 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
    Dna-reagents, neisseria - Product Code LSL
  • Cause
    Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
  • Action
    An Urgent Medical Device Recall letter (response form included), dated October 9, 2017, was sent to affected consignees. The letter identified the affected product, the issue involved, impact, and actions to be taken. Cepheid will provide replacement product for Xpert CT/NG assay product identified in this recall. Customers are to complete and the return the Response Form provided in order to receive replacement product. Additionally, the letter instructs users to review their laboratory statistics to see if their positivity rates are trending low during use of the affected lots. If so, they are to review the negative patient results according to their laboratory's Quality Management System. Customers are to refer to the applicable contact information provided if there are any questions.

Device

Xpert CT/NG
  • Modèle / numéro de série
    Lot numbers: 25718, 25719, 25725, and 25727.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Puerto Rico, and Haiti.
  • Description du dispositif
    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. || Is a qualitative in vitro real-time PCR test.
  • Manufacturer
    Cepheid

Manufacturer

Cepheid
  • Adresse du fabricant
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA