Events

Rappel de MicroVue CICC1q EIA

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 Diagnostic Hybrids, 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
    79629
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1496-2018
  • Date de mise en oeuvre de l'événement
    2017-04-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162851
  • 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
    Complement c1q, antigen, antiserum, control - Product Code DAK
  • Cause
    There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
  • Action
    Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter.

Device

MicroVue CICC1q EIA
  • Modèle / numéro de série
    Lot 084007
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.
  • Description du dispositif
    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. || The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
  • Manufacturer
    Diagnostic Hybrids, Inc.

Manufacturer

Diagnostic Hybrids, Inc.
  • Adresse du fabricant
    Diagnostic Hybrids, Inc., 2005 E State St Ste 100, Athens OH 45701-2125
  • Société-mère du fabricant (2017)
    Quidel Corporation
  • Source
    USFDA