Events

Rappel de Dimension Vista Gentamicin 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
    80009
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2182-2018
  • Date de mise en oeuvre de l'événement
    2018-04-19
  • 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=164206
  • 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
    Enzyme immunoassay, gentamicin - Product Code LCD
  • Cause
    The affected lots may exhibit inaccuracy for quality control and patient samples at the low end of the analytical measurement range. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators. the negative bias observed for patient, qc, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/ml [5.4 ¿mol/l].
  • Action
    On April 19, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter identified the affected lots and advised customers to do the following: Inspect stock, discontinue use of and discard the Dimension and Dimension Vista GENT lots listed in Table 1. ¿ 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 regulatory 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.

Device

Dimension Vista Gentamicin Flex reagent cartridge
  • Modèle / numéro de série
    Lots 17135BC 17150BF 17159BD 17178AC 17269BD 17312BB
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
  • Description du dispositif
    Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and || 17312BB.
  • 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