Events

Rappel de Device Recall Spectrolyse PAI1

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 Sekisui Diagnostics Llc.

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
    63016
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2431-2012
  • Date de mise en oeuvre de l'événement
    2012-08-28
  • Date de publication de l'événement
    2012-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112279
  • 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
    Test, qualitative and quantitative factor deficiency - Product Code GGP
  • Cause
    Spectrolyse pai-1 activity assay producing lower than expected absorbance values with "0" standard. this will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
  • Action
    The firm, Sekisui Diagnostics, LLC, sent an "URGENT PRODUCTS RECALL NOTICE" dated August 28, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to immediately stop using the product; to discard any remaining inventory and complete and return the Customer Acknowledgement Form by September 4, 2012 documenting the # of kits destroyed via FAX to Quality Assurance at 203-602-5553. The customers were also instructed to return the form even if they do not have the affected product currently in inventory. Sekisui will replace kits. If you have any questions contact, Customer Service Department at 800-637-3375, ext 10, 12, or 31, or email to recall coordinator at MKHAN@AMDIAG.COM.

Device

Device Recall Spectrolyse PAI1
  • Modèle / numéro de série
    Lot Numbers: 120425 and 120601
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, IN, IL, and WA.
  • Description du dispositif
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. || Catalog Number: 101201 || For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
  • Manufacturer
    Sekisui Diagnostics Llc

Manufacturer

Sekisui Diagnostics Llc
  • Adresse du fabricant
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • Société-mère du fabricant (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA