Events

Rappel de Device Recall LIFECODES PF4 Enhanced assay

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 Genetic Testing Institute,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
    64501
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1022-2013
  • Date de mise en oeuvre de l'événement
    2013-02-04
  • Date de publication de l'événement
    2013-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116359
  • 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
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • Cause
    Lifecodes pf4 enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit positive control and patient samples. the variation in reactivity can lead to invalid assays. if an invalid assay is obtained, those results should not be reported and the test should be re-run. an invalid assay would not result in significant harm to a pati.
  • Action
    Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or waukeshatechsupport@gen-probe.com. For questions regarding this recall call 262-754-1026.

Device

Device Recall LIFECODES PF4 Enhanced assay
  • Modèle / numéro de série
    Kit Lot Number 3000389
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
  • Description du dispositif
    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 || GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
  • Manufacturer
    Genetic Testing Institute,inc

Manufacturer

Genetic Testing Institute,inc
  • Adresse du fabricant
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA