Events

Rappel de Device Recall Dimension QuikLYTE Dilution Check

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
    70627
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1398-2015
  • Date de mise en oeuvre de l'événement
    2015-02-24
  • Date de publication de l'événement
    2015-04-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134171
  • 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
    Electrode, ion specific, potassium - Product Code CEM
  • Cause
    A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. the dilution check correction would be detected by qc; however, if not detected by qc, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.
  • Action
    An Urgent Medical Device Recall letter, dated February 2015, was provided to all Dimension¿ system customers who received the affected lot to notify them that Siemens confirmed customer complaints of failing dilution checks when using QuikLYTE Dilution Check lot 4MD707. The letter also instructed them to immediately discontinue use and discard all inventory of Dimension QuikLYTE¿ Dilution Check lot 4MD707. Siemens offered a no charge replacement with a non-impacted lot.

Device

Device Recall Dimension QuikLYTE Dilution Check
  • Modèle / numéro de série
    Catalog Number S640, Siemens Material Number (SMN) 10444872, Lot Number 4MD707
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. || Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.
  • 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