Events

Rappel de Device Recall Human Alpha1Antitrypsin 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 The Binding Site Group, Ltd..

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
    78047
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0002-2018
  • Date de mise en oeuvre de l'événement
    2017-08-23
  • Statut de l'événement
    Completed
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158557
  • 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
    Alpha-1-antitrypsin, antigen, antiserum, control - Product Code DEM
  • Cause
    The high control for the kit is recovering low and may be out of range for assigned values.
  • Action
    Binding Site sent an Field Safety Notice dated August 24, 2017, explaining the reason for recall and requesting the direct account and their customer to remove the affected kits from inventory and dispose of them. The direct account and their customers were instructed to circulate the field safety notice to other persons who use the product within their organization. A response form, to be returned via email, was enclosed for completion to indicate the number of kits discarded. For further questions, please call (858) 453-9177.

Device

Device Recall Human Alpha1Antitrypsin Kit
  • Modèle / numéro de série
    Lot #400900, Exp. 12/31/2017, UDI #05051700016421
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.
  • Description du dispositif
    Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. || Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
  • Manufacturer
    The Binding Site Group, Ltd.

Manufacturer

The Binding Site Group, Ltd.
  • Adresse du fabricant
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • Société-mère du fabricant (2017)
    Cidron Iugo Sarl
  • Source
    USFDA