Events

Rappel de Device Recall Dimension Vista Calcium (CA) Flex Reagent cartridge

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
    79593
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1540-2018
  • Date de mise en oeuvre de l'événement
    2018-01-30
  • 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=162736
  • 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
    Cresolphthalein complexone, calcium - Product Code CIC
  • Cause
    May produce erroneously low results from specific well sets.
  • Action
    An Urgent Medical Device Recall and an Urgent Field Safety Notice were issued on January 30, 2018 to all Dimension Vista customers who purchased the impacted lot to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: "Discontinue use of and discard the Dimension Vista Calcium Flex reagent lot 17171BD. "Please review this letter with your Medical Director. "Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. "Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.

Device

Device Recall Dimension Vista Calcium (CA) Flex Reagent cartridge
  • Modèle / numéro de série
    Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
  • Description du dispositif
    Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 || The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, Po Box 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA