Events

Rappel de Device Recall Troponin I Immunoassay

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 Roche Diagnostics Operations, 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
    61249
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1387-2012
  • Date de mise en oeuvre de l'événement
    2012-03-12
  • Date de publication de l'événement
    2012-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107659
  • 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
  • Cause
    An investigation has confirmed a considerably reduced recovery of li-heparin plasma samples for troponin i lot 163176 and troponin i stat lot 163177. in the worst case, li-heparin sample recovery may be as low as 50% of the serum recovery. correct serum recovery has been confirmed for the affected lots. the issue is caused by the raw material lot (poly-l-lysin) instability. poly-l-lysin is the.
  • Action
    The firm, Roche Diagnostics Corporation, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 12, 2012 to all customers that received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the affected product; discard the affected product from their inventory according to their site's local regulations; if their facility has distributed the affected product to other sites, ensure that this letter is provided to those sites; complete and return the attached fax form via fax to 1-888-912-8457 and file this letter for future references. If you have any questions about the information contained in this letter, please contact Roche Diagnostics Technical Support, 24 hours a day, seven days a week at 1-800-428-2336.

Device

Device Recall Troponin I Immunoassay
  • Modèle / numéro de série
    Elecsys Troponin I Immunoassay, 05094810160- lot 163176
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. Argentina, Kenya, Austria, South Korea, Belgium, Kuwait, Bahrain, Morocco, Brazil, Mexico, Switzerland, Nigeria, Chile, New Zealand, Columbia, Philippines, Germany, Pakistan, Algeria, Poland, Egypt, Qatar, Spain, Tunisia, France, Turkey, United Kingdom, Taiwan, India, Ukraine, Iran, Venezuela, Italy, South Africa, Jordan, and Armenia.
  • Description du dispositif
    Elecsys Troponin I Immunoassay || For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA