Events

Rappel de Device Recall BD FACS Sample Prep Assistant (SPA and SPA II)

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
    51208
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1620-2011
  • Date de mise en oeuvre de l'événement
    2009-01-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79200
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Cause
    To prevent a needle stick while replacing the probe, the firm has initiated a field correction, and issued an improved users guide procedure (user bulletin, part number 645050).
  • Action
    The firm, BD Biosciences, sent an information letter dated December 2008 with an enclosed New Probe Replacement Service/User Bulletin, to the customers. The letter described the product, problem and action to be taken. The customers were instructed to review the attached User Bulletin (Part Number 645050); ensure that their laboratory follows the updated procedure for removing and replacing probe; place the User Bulletin in their BD FACS SPA or SPA II User's Guide; always follow the instructions in User Bulletin to properly remove and replace probe, and complete and return the Effectivity Form via fax to 408-577-1409. Should you have any comments or questions, please contact BD Biosciences at 1-877-232-8995 in the US. Outside the US, contact your regional BD office or field service engineer for assistance.

Device

Device Recall BD FACS Sample Prep Assistant (SPA and SPA II)
  • Modèle / numéro de série
    Lot Number: T0040
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Hong Kong, Australia, Belgium, Canada, El Salvador, Hong Kong, Japan, and Mexico.
  • Description du dispositif
    BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, || Model Number: 334080, || Product is manufactured and distributed by BD Biosciences, San Jose, CA || The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.
  • 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