Events

Rappel de Device Recall PhoenixSpec Calibrator & Kit

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
    75375
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0311-2017
  • Date de mise en oeuvre de l'événement
    2016-06-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150165
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Cause
    Bd has determined that the bbl phoenixspec calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). the expiration date printed on the individual calibration tubes within the kit are correct but difficult to read on a portion of the tubes.
  • Action
    All US customers were contacted via letters sent via UPS. Ex-US BD sites will contact customers in their local regions. The firm will use an acknowledgement form included with the follow up letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement

Device

Device Recall PhoenixSpec Calibrator & Kit
  • Modèle / numéro de série
    Part/Catalog Number.: 440911, 441951  Lot / Serial Number. :5364776, 5345796
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    BD has contacted all 31 US customers and 22 Ex-US sites which received product from the associated catalog numbers. US: AL, CA, CO, KY, MD, MI, MS, NE, NJ, OH, PA, SC, SD, TX, VA, WA and WI. Ex-US: Argentina, Europe, Canada, China, Ecuador, India, Japan, New Zealand, Peru, Singapore, Thailand and Vietnam 4 US government sites were contacted
  • Description du dispositif
    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, BD Diagnostic Systems, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA