Events

Rappel de Device Recall Dimension Mass Creatine Kinase MB Isozyme Calibrator

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
    65152
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1925-2013
  • Date de mise en oeuvre de l'événement
    2013-06-05
  • 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
    2015-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118035
  • 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, secondary - Product Code JIT
  • Cause
    Siemens healthcare diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the mmb calibrator instructions for use (ifu). the frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated May 2013, to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Until a permanent solution is identified, please follow the instructions listed in the letter in order to optimize calibration preparation; complete and return the attached Correction Effectiveness Check form via fax to the Siemens Technical Solutions Center at (302) 631-8467 and forward this notification to anyone to whom you may have distributed this product. If you have any questions, please contact the Siemens Technical Solutions Center or your local Siemens technical representative or call 800-441-9250.

Device

Device Recall Dimension Mass Creatine Kinase MB Isozyme Calibrator
  • Modèle / numéro de série
    Product - MMB CAL, Catalog Number RC420, Siemens Material Number 10445023 with lot numbers 2GD053, 2KD024, and 3AD051.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: US including states of : AK, AL, AR, AZ, CA, CO, CT, DC, GA, GU, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Description du dispositif
    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) || The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
  • 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