Events

Rappel de Siemens ADVIA Centaur Vitamin D Total 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
    75394
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0397-2017
  • Date de mise en oeuvre de l'événement
    2016-10-05
  • Statut de l'événement
    Open, Classified
  • 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=150188
  • 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, vitamin d - Product Code MRG
  • Cause
    Vitamin d total- change in correlation between serum and plasma specimen tubes- negative bias with plasma vs. serum samples.
  • Action
    Siemens issued an Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on October 5, 2016 to be delivered to customers on October 6th, 201 6. An Urgent Field Safety Notice ~UFSN) was sent out for distribution to all customers outside the United States on October 5, 2016. These notices inform the customer of the change in correlation between serum and plasma specimen tube results generated on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT Vitamin D Total assay. A revised letter was issued on November 7, 2016 by Fedx for delivery on November 8, 2016 and advises users to: In the interim, Siemens requires that customers discontinue use of plasma tubes for specimen collection for the ADVIA Centaur Vitamin D Total assay until further notice. Customers can continue to use the ADVIA Centaur Vitamin D Total assay with serum specimen collection tubes. Accounts to Complete and return the Field Correction Effectiveness Check Form attached within 30 days. Review the letter with your Medical Director. and retain this letter with your laboratory records, and forward this letter to those who may have received this product. Question contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Siemens ADVIA Centaur Vitamin D Total Assay
  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Foreign: Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Georgia, Germany, Great Britain, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Jordan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, Uruguay, Vietnam
  • Description du dispositif
    Siemens ADVIA Centaur¿ Vitamin D Total Assay || SMN 10699201 (100 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