Events

Rappel de Device Recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress

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 Siemens Healthcare Diagnostics, 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
    71363
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1843-2015
  • Date de mise en oeuvre de l'événement
    2015-05-06
  • Date de publication de l'événement
    2015-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137452
  • 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
    System, test, radioallergosorbent (rast) immunological - Product Code DHB
  • Cause
    Immulite 2000/2000xpi italian cypress (t23l4), lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.
  • Action
    Siemens Healthcare Diagnostics issued an Urgent Medical Device Recall Letter (IMC-15-11A.US, dated May 6, 2015) in the US via FedEx, and an Urgent Field Safety Notice (IMC-15-11A.OUS, May 2015) outside the US on May 6, 2015. Customers were instructed to immediately discontinue use of and discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Discontinue use and discard lot 208 after June 30, 2015. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days in the US and OUS and fax to Customer Care Center at 312-275-7795.

Device

Device Recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress
  • Modèle / numéro de série
    Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.
  • Description du dispositif
    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA