Events

Rappel de IMMULITE/IMMULITE 1000 Turbo Troponin I

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
    69718
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0801-2015
  • Date de mise en oeuvre de l'événement
    2014-10-27
  • Date de publication de l'événement
    2014-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131414
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated October 27, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of and discard the kit lots listed; review this letter with your Medical Director, complete and return the Field Correction Effectiveness Check attached to this letter within 7 days via fax to: the Customer Care Center at (312) 275-7795; report any complaints or AE associated with the product to your local Siemens Customer Care Center or your local Siemens technical support representative; contact your local Siemens technical support representative to discuss alternative Siemens solutions; retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, contact your local Siemens technical support representative or 914-524-3074.

Device

IMMULITE/IMMULITE 1000 Turbo Troponin I
  • Modèle / numéro de série
    Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.
  • Description du dispositif
    Turbo Troponin I || For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
  • 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