Events

Rappel de Device Recall Alere Cholestech LDX 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 Alere San Diego.

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
    60391
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0964-2012
  • Date de mise en oeuvre de l'événement
    2010-11-16
  • Date de publication de l'événement
    2012-02-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105233
  • 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 CHH
  • Cause
    Alere has identified that a bias on results for certain analytes tested on the alere cholestech ldx system may exist due to humidity variability.
  • Action
    Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email LDXROM@alere.com to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at LDXROM@alere.com with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at LDXROM@alere.com.

Device

Device Recall Alere Cholestech LDX System
  • Modèle / numéro de série
    ROM versions prior to 3.40
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution including USA
  • Description du dispositif
    Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
  • Manufacturer
    Alere San Diego

Manufacturer

Alere San Diego
  • Adresse du fabricant
    Alere San Diego, 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA