Events

Rappel de NOVA Lite ANA KSL Kit

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 Inova Diagnostics Incorporated.

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
    60219
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0280-2012
  • Date de publication de l'événement
    2011-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104801
  • 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 DHN
  • Cause
    The nova lite ana ksl kit label has the wrong fill volume for the ifa system negative control (p/n 508186) with 1ml. the component in the kit is correctly labeled and filled with the 0.5ml fill volume.
  • Action
    On 9/26/11, Inova Diagnostics forwarded an Urgent Advisory Notice and Product Advisory Notice Fax Back Form to all their customers who purchased the Nova Lite Ana KSL, Product Code: 708390. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete the attached fax back form indicating how many of these kits they have in their inventory, quantity destroyed, method of destruction and the quantity of kits that need to be replaced. Customers were also instructed to notify their customers of the advisory notice. Customers were instructed to contact Tana Keivens with any questions or comments at (858) 586-9900 ext 351.

Device

NOVA Lite ANA KSL Kit
  • Modèle / numéro de série
    070409, 070491, 170069, 17014E1, 170214E2, 170440
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.
  • Description du dispositif
    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit || Part Number: 708390. in vitro diagnostic.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Adresse du fabricant
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA