Events

Rappel de Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges

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
    57631
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1729-2011
  • Date de mise en oeuvre de l'événement
    2010-12-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96911
  • 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
    Alkaline picrate, colorimetry, creatinine - Product Code CGX
  • Cause
    Firm has confirmed the potential for falsely elevated creatinine results with specified crea flex(r) reagent cartridge lots when processing tests from a well that has been punctured. this issue may affect creatinine results for quality control (qc) and patient samples.
  • Action
    The firm, SIEMENS, sent an "Urgent Field Safety Notice" dated December 2010 to all customers. The letter described the product ( Dimension(R) CREA Flex(R) Reagent Cartridges DF33A lots BB1286, CA1260 and FB1251), problem and actions to be taken. The customers were instructed to please discontinue use and discard any remaining inventory of the product; complete and return the fax form to the Customer Service Support for replacement of the product; if they must continue use of the product until they receive a replacement, open a new well set every 8 hours to minimize any impact to CREA test results, and complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to the Technical Solution Center at 302-631-8467. If you have any questions, contact the Technical Solution Center at 800-441-9250.

Device

Device Recall Dimension(R) Creatinine Flex(R) Reagent Cartridges
  • Modèle / numéro de série
    Catalog Number DF33A - Lots BB1286, CA1260 and FB1251
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: United States and the following foreign countries: Austria, Belgium, Bosnia and Herzegovina, Canary Islands, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Great Britain, Greece, Hungary, Italy, Latvia, Lithuania, Kuwait, Macedonia, Morocco, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey and the United Arab Emirates.
  • Description du dispositif
    Dimension(R) Creatinine Flex(R) Reagent Cartridges || The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine 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 Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA