Events

Rappel de Device Recall BD FACSCanto Plus

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 Biosciences, Systems & Reagents.

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
    68490
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1977-2014
  • Date de mise en oeuvre de l'événement
    2014-06-06
  • Date de publication de l'événement
    2014-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128033
  • 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
    Flow cytometric reagents and accessories. - Product Code OYE
  • Cause
    Laser cooling fans and internal fan of the associated fluidics cart are not operational.
  • Action
    BD sent an Important Product Recall notification letters dated June 2014 to affected US customers by trackable mail. International affiliates were notified on June 6, 2014. The letter identified the affected product, problem and the actions to be taken. A Field Change notification has been established and a BD field Service Engineer will coordinate with each account to perform the necessary corrections. Questions or concerns may be directed to BD Customer Support at BD Biosciences, prompt 2. Out of US customers are to contact local BD rep with questions.

Device

Device Recall BD FACSCanto Plus
  • Modèle / numéro de série
    FACS Canto: model number 657338; Associates Fluidic Cart (catalog number 6657660)- IVD; Serial numbers:  V65733800001, V65733800002, V65733800003, V65733800004 V65733800005, V65733800006, V65733800007, V65733800008, V65733800009, V657338000010, V657338000011, V657338000012, V657338000013, V657338000014, V657338000017, V657338000018, V657338000019, V657338000020, V657338000021, V657338000022, V657338000023, V657338000024, V657338000025, V657338000026, V657338000028, V657338000029, V657338000031, V657338000032, V657338000033, V657338000034, V65733800035, V65733800036, V65733800037, V65733800038, V65733800039, V657338000040 V657338000043, V657338000044, V657338000045, V657338000046, V657338000047, V657338000048, V657338000049, V657338000050, V657338000051, V657338000052, V657338000053, V657338000054, V657338000055, V657338000056, V657338000057, V657338000058, V657338000060.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.
  • Description du dispositif
    BD FACS Canto and associated Fluidics Cart || Product Usage: Flow cytometer for use in In vitro Diagnostics.
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

BD Biosciences, Systems & Reagents
  • Adresse du fabricant
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA