Events

Rappel de Device Recall QuantiFERON TBGold

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 Qiagen Sciences LLC.

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
    73384
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1230-2016
  • Date de mise en oeuvre de l'événement
    2016-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143995
  • 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
    Test, immunity, cell mediated, mycobacterium tuberculosis - Product Code NCD
  • Cause
    Potential for obtaining a false positive result due to the possibility of endotoxin presence.
  • Action
    QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: TechService-NA@qiagen.com or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.

Device

Device Recall QuantiFERON TBGold
  • Modèle / numéro de série
    CODE(S):   a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016  b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016  c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016  d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016  e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
  • Description du dispositif
    QFT TB Antigen Tube. || QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
  • Manufacturer
    Qiagen Sciences LLC

Manufacturer

Qiagen Sciences LLC
  • Adresse du fabricant
    Qiagen Sciences LLC, 19300 Germantown Rd, Germantown MD 20874-1415
  • Société-mère du fabricant (2017)
    QIAGEN N.V.
  • Source
    USFDA