Events

Rappel de Device Recall N Latex IgM

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
    70385
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1289-2015
  • Date de mise en oeuvre de l'événement
    2015-01-15
  • Date de publication de l'événement
    2015-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133400
  • 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
    Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
  • Cause
    Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some n latex igm reagent kit lots 44018, 44019 and 44042.
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated January 2015 to its customers on January 13, 2015. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Discontinue use of the affected lots and discard any remaining material; Identify if IgM quotient was overestimated due to falsely low IgM results with serum sample; Reconsider patient diagnosis taking other patient data into consideration.; When other patient data does not support the result for an intrathecal IgM synthesis or inflammation, re-measurement of samples may be considered using and alternative lot. In addition, Siemens requested customers to review this letter with their Medical Director; to complete and return the attached Effectiveness Check/Product Replacement form via fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center 800-441-9250 or email: aydee.I.crawford@siemens.com or your local Siemens technical support representative.

Device

Device Recall N Latex IgM
  • Modèle / numéro de série
    Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.
  • Description du dispositif
    N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune 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