Events

Rappel de Device Recall BD BACTEC FX Top Unit instrument

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
    67245
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0869-2014
  • Date de mise en oeuvre de l'événement
    2013-12-09
  • Date de publication de l'événement
    2014-01-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125074
  • 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
    System, blood culturing - Product Code MDB
  • Cause
    Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
  • Action
    BD Diagnostics initiated a field correction by phone on December 9, 2013, to affected customers and followed the calls with letters, e-mails, or fax. BD Diagnostics sent a secondary Urgent Field Corrective Action letter dated November 2013 to all affected customers. The recalling firm Secondary notifications were serial number specific and explained that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights which should appear yellow may instead appear more green in color. BD noted that affected instruments continue to function properly and will not report an incorrect result. The issue is limited to the yellow indicator lights only. Red and green indicator lights appear as intended. BD is developing software to correct this issue and anticipates that the new software will be available to begin instrument updates by February, 2014. The new software will not affect instrument if the indicator lights are functioning as intended. Until the software can be updated on your instrument, BD provided workflow instructions to ensure that the indicator light issue does not occur. For questions regarding this recall call 410-316-4054.

Device

Device Recall BD BACTEC FX Top Unit instrument
  • Modèle / numéro de série
    Catalog number 441385 and 441386
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
  • Description du dispositif
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. || The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
  • 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