Events

Rappel de Device Recall Vidiera NsP Nucleic Sample Preparation

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 Beckman Coulter Inc.

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
    48660
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0454-2009
  • Date de mise en oeuvre de l'événement
    2007-08-30
  • Date de publication de l'événement
    2008-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71828
  • 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
    Pipetting and diluting system for clinical use. - Product Code JQW
  • Cause
    Incorrect results: under certain circumstances, when transfer volume is not within the set range, the vidiera nsp software does not report sample exclusion and does not flag the excluded sample in the "run results" report. the software error associated with the excluded sample appears as "liquid was not successfully transferred to well#..........The sample will be excluded from further proce.
  • Action
    The customer notifications were initiated by Beckman Coulter on September 11, 2007 when all affected accounts were contacted via telephone, followed by a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers of the issue and instructed them to: (1) Review the "run Summary" event log for your samples. (2) Review the attached instructions describing the steps for identifying the samples affected by this error. (3) Complete and return the enclosed response form within 10 days so that we may maintain our records. The letter informed the customers that Beckman Coulter would provide a software update within 60 days. The letter also asked their customers to share the PCA with their staff and provide a copy of the PCA to any customers that they may have forwarded the affected products to. For questions regarding the PCA, please contact firm at 714-961-3634.

Device

Device Recall Vidiera NsP Nucleic Sample Preparation
  • Modèle / numéro de série
    Part Numbers: A22421, Version 1.0.41
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution including states of PA, MI, UT, WA, IL, and CA.
  • Description du dispositif
    Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA