Events

Rappel de Siemens Healthcare Diagnostics ADVIA Centaur Calibrator U

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
    74951
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2899-2016
  • Date de mise en oeuvre de l'événement
    2016-08-08
  • 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=148887
  • 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
    Myoglobin, antigen, antiserum, control - Product Code DDR
  • Cause
    Failure of analytical sensitivity with calibrator u kit lots ending in 63 and 64 and a drift from the internal standardization.
  • Action
    Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction (UMDC) to customers in the US on August 8, 2016, to be delivered to customers on August 9, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on August 8, 2016. The communications notify customers of the failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization. The communications also inform customers that analytical sensitivity and alignment to the internal standardization will be restored with the release of Calibrator U kit lots ending in 65. Customers may continue to use Calibrator U lots CU63 and CU64 with any indate reagent kit lot, current QC ranges and current Master Curve Material lot 45719. Revised QC targets and ranges are located on the Bio-Rad website at QCnet.com for use with CU65 and higher. For further questions, please call (508) 668-5000.

Device

Siemens Healthcare Diagnostics ADVIA Centaur Calibrator U
  • Modèle / numéro de série
    Kit Lots ending in 63 and 64 as follows: 65710A63, 77825A63, 99481A64, 08835A64, 22955A64
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa
  • Description du dispositif
    Siemens ADVIA Centaur¿ Calibrator U, || For in vitro diagnostic use in calibrating the following assays using || ADVIA Centaur"' systems: Myoglobin cTnl || Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
  • 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