Events

Rappel de ADVIA Centaur BNA Assay

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
    69461
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0229-2015
  • Date de mise en oeuvre de l'événement
    2014-10-06
  • Date de publication de l'événement
    2014-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130717
  • 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,natriuretic peptide - Product Code NBC
  • Cause
    Siemens healthcare diagnostics has confirmed that approximately 2000 readypacks from the advia centaur¿ systems bnp reagent contains an advia centaur systems ft4 human-readable side label.
  • Action
    A Customer Notification (CN) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 03, 2014 to be delivered to customers on October 06, 2014 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 06, 2014. These notices inform the customer of the potential to receive an ADVIA Centaur BNP ReadyPack with a FT4 human-readable side label. Siemens instructs customers to inspect their inventory and discard any BNP Readypacks with a FT4 side label. In addition, Siemens informs customers the end labels of the affected ReadyPacks correctly identify the pack as BNP and Siemens has confirmed the reagent within these packs is BNP Reagent. Therefore valid BNP results will be generated when calibrating and running quality control or patient samples. Fax-back forms will be used to confirm that the customers received the notification. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Customer Notification and completed the required actions.

Device

ADVIA Centaur BNA Assay
  • Modèle / numéro de série
    Lot 038174: 100 Test - 43305174 and 43278174; 500 Test - 43306174 and 43279174.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including Puerto Rico; and countries of: Canada, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Fren.Polynesia, Germany, Great Britain, Greece, Guadeloupe, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Reunion, Russian Fed., Slovakia, Slovenia, Spain, Switzerland, Turkey, Unit.Arab Emir., AR, AU, BR, CL, CN, CR, IN, JP, KR, LK, MY, SG, TW, UY, VN, and ZA.
  • Description du dispositif
    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: || Cat No. 02816138/SMN 10309044 (100 test) || 02816634/SMN 10309045 (500 test)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA