Events

Rappel de Device Recall FastPack Vitamin D 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
    66842
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0550-2014
  • Date de mise en oeuvre de l'événement
    2013-11-08
  • Date de publication de l'événement
    2013-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123731
  • 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
    System, test, vitamin d - Product Code MRG
  • Cause
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Action
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.

Device

Device Recall FastPack Vitamin D Immunoassay
  • Modèle / numéro de série
    Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • Description du dispositif
    FastPack Free T4 Immunoassay || FastPack Vitamin D Immunoassay || Chemilunescence assay for the determination of Vitamin D || The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay 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.
  • 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