Events

Alerte De Sécurité sur QIAamp DSP Virus Kit CE

Selon Food and Drug Administration Philippines, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Philippines qui a été fabriqué par manufacturer #17352.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    2017-251
  • Pays de l'événement
    Philippines
  • Source de l'événement
    FDAP
  • URL de la source de l'événement
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/455269-fda-advisory-no-2017-251
  • Notes / Alertes
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Notes supplémentaires dans les données
  • Cause
    Fda advisory no. 2017-251 voluntary recall of qiaamp dsp virus kit  ce all concerned healthcare professionals are hereby advised by the food and drug administration (fda) regarding the recall of qiaamp dsp virus kit ce (see photos of the product below) distributed by getz bros. phils., inc. the qiaamp dsp virus kit is a generic system that uses silica-membrane technology (qiaamp technology) for isolation and purification of viral nucleic acids from human plasma or serum for in vitro diagnostic purposes. the following lot numbers distributed after 2 september 2016 are affected by the recall: 154025928, 154027751, 154029053, 154029743 and 154029744 all other batches of the product produced before and after this issue are not affected. the above-stated medical device products are being voluntary recalled by getz bros. phils., inc. an investigation revealed that the root cause of the issue was a deviation from the correct storage conditions which led to reduced stability and decreased performance. the performance of the eluates obtained with the qiaamp dsp virus kit with lot numbers mentioned above in downstream applications could be reduced which may lead to the following consequences: in downstream applications, with controls processed through sample preparation, may lead to an increased number of invalid results in quantitative downstream applications, without controls processed through sample preparation, lower quantification and false negative cannot be ruled out. in qualitative downstream applications, without controls processed through sample preparation, false negative results cannot be ruled out. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-251.Pdf.

Device

QIAamp DSP Virus Kit CE

Manufacturer

manufacturer #17352