Events

Rappel de Device Recall DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107)

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
    65706
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1924-2013
  • Date de mise en oeuvre de l'événement
    2013-07-01
  • Date de publication de l'événement
    2013-08-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119941
  • 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, tracrolimus - Product Code MLM
  • Cause
    Siemens initiated a recall due to confirmed complaints of low patient sample recovery with dimension tacr flex reagent cartridge (df107) lot bb4087 and its linked calibrator (dc 107) lot 3bd029. falsely low tacrolimus results across the assay range may lead to alterations in dosing.
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated July 2013 to affected customers The letter identified the affected product, problem, potential risk, and actions to be taken by customers. Customers were requested to discuss the letter with thier laboratory director to determine if additional follow up is appropriate for patient tests conducted with the affected device lots. Additionally, customers were asked to discard any remaining inventory and to complete and return the field correction effectiveness check for replacement product. They were also asked to forward the letter to anyone wha had received this affected product. For questions contact your Siemens Technical Solutions Center or your local Siemens Technical support representative.

Device

Device Recall DimensionTACR (DF107) and Dimension Tacrolimus Calibrator (DC107)
  • Modèle / numéro de série
    TACR Flex Reagent cartridge, material #10444938, (DF107) lot BB4087 with expiration date 3/28/14 and its linked calibrator, material #10445012, (DC 107) lot 3BD029 with expiration date 03/01/14.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution including the states of: TX, NC, GA, TN, UT, NJ, MI, VA, AR, LA, MO, FL, AZ, CA, DC, PA, NH, WI, SD, SC, NM, MD, and IN.
  • Description du dispositif
    Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) || Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
  • 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