Events

Rappel de ADVIA 2400 Chemistry System

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 Bayer Healthcare, LLC (Diagnostics Division).

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
    36713
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0353-2007
  • Date de mise en oeuvre de l'événement
    2006-09-08
  • Date de publication de l'événement
    2007-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49709
  • 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
    in vitro diagnostic - Product Code LEG
  • Cause
    Bayer received a customer complaint where the valproic acid quality control material recovered lower than target when it was run in a panel of other therapeutic drug (tdm) assays. the under recovery observed by the customer was approximately -25%. investigation into this issue was initiated promptly following receipt of this complaint.
  • Action
    On 9/08/06, a Support Bulletin was sent to all affected Bayer HealthCare LLC Branches in order to inform them of the issue and to provide them with instructions for the 'field correction'. On 9/08/06, a Customer Bulletin was sent to all affected Bayer HealthCare LLC Branches both in the US and worldwide for communication with the affected end user customers. The bulletin advises of the problem and the corrective action. A Completion Confirmation (Fax-back) Form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. The Customer Bulletin is to be sent to all affected end user customers. Bayer Technical Service Specialists will follow-up with all of the ADVIA Chemistry System customers to make sure they have understood the bulletin and to ask that they return the FAX-back Completion Confirmation Form to Bayer HealthCare. If Bayer HealthCare does not receive the form in a timely manner, specialists in the Bayer Technical Care Center will contact the customer through whatever means possible in an effort to obtain 100% effectiveness on this communication.

Device

ADVIA 2400 Chemistry System
  • Modèle / numéro de série
    All ADVIA 2400 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 2400 Part # 073-A010, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • Description du dispositif
    ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)
  • Adresse du fabricant
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
  • Source
    USFDA