Events

Rappel de FastPack Total PSA Immunoassay

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 Qualigen 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
    50115
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0500-2009
  • Date de publication de l'événement
    2008-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74758
  • 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
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
  • Cause
    The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
  • Action
    The recall was initiated with Qualigen faxing a copy of the Product Notification letter, dated 9/29/2008, to all customers who have received any sublot of the affected product . Faxes were sent beginning 9/29/08. The recall letter informed the customers that the affected product was not meeting the firm's expectations for product performance. Customers were instructed to please stop using the affected lots immediately as they have been noted to produce falsely elevated results and they should confirm any result that appears to be inconsistent with "a patient's medical history, clinical examination, and other findings". In addition, they may wish to retest any patients that were run with a different FastPack lot. Beginning on 9/30/08, all customers were contacted by phone to confirm that they received the recall letter. The customers were shipped replacement products at no cost and as part of the product replacement process, they were instructed to return any unused Total PSA FastPacks/Kits of lot 0807002 to Qualigen.

Device

FastPack Total PSA Immunoassay
  • Modèle / numéro de série
    Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.
  • Description du dispositif
    FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 || Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
  • Manufacturer
    Qualigen Inc

Manufacturer

Qualigen Inc
  • Adresse du fabricant
    Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
  • Société-mère du fabricant (2017)
    Qualigen Inc
  • Source
    USFDA