Events

Rappel de Siemens Dimension Vista CHEM 1 CAL

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
    69063
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2720-2014
  • Date de mise en oeuvre de l'événement
    2014-08-18
  • Date de publication de l'événement
    2014-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129484
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Cause
    Siemens healthcare diagnostics has received complaints for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista® chem 1 cal, lot 3gm081. investigation by siemens confirms that qc and patient samples under-recovers mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.
  • Action
    Siemens sent an Urgent Medical Device Dorrection letter, dated August 2014, to all affected consignees. The letter identified the product, the problem, and the actions to be taken. Consignees were instructed if they still have an active calibration of MG with this lot of CHEM 1 CAL, they should immediately calibrate MG with an alternate lot of CHEM 1 CAL. Consigness were instructed to retain the letter with their laboratory records, and to forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center - Techhnical Solutions or their local Siemens technical support representative.

Device

Siemens Dimension Vista CHEM 1 CAL
  • Modèle / numéro de série
    lot 3GM081, exp. 07-01-2014
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland
  • Description du dispositif
    Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. || The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods 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