Events

Rappel de Device Recall BD MAX System

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 BD LIFE SCIENCES.

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
    76900
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1864-2017
  • Date de mise en oeuvre de l'événement
    2015-07-29
  • Date de publication de l'événement
    2017-04-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154530
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Cause
    The bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. customers utilizing only ivd assays are not affected. this anomaly may cause the osr customer system to incorrectly switch the columns of the truth table on the users display. if the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. bd is able to trace the issue to a limited number of instruments that have software version 4.44a installed. note that the problem only affects customers that are either creating a new udp with result logic or modifying the result logic of an existing udp.
  • Action
    BD sent an Urgent Field Corrective Action Recall notification was initiated on July 29, 2015. The customer was initially contacted via a phone call and subsequently provided with a written communication. All US customers were contacted directly by phone and provided the written communication. Global holds were placed on July 21, 2015 and July 24, 2015. For further questions, please call (410) 316-4000.

Device

Device Recall BD MAX System
  • Modèle / numéro de série
    Catalog number 441916
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.
  • Description du dispositif
    Software version 4.44A utilized on the BD MAX System
  • Manufacturer
    BD LIFE SCIENCES

Manufacturer

BD LIFE SCIENCES
  • Adresse du fabricant
    BD LIFE SCIENCES, 54 Loveton Cir, Sparks Glencoe MD 21152-9202
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA