Events

Rappel de Device Recall Consult Diagnostics Eon Calcium Reagent For InVitro Diagnostic Use

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 Vital Diagnostics, 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
    66202
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0733-2014
  • Date de mise en oeuvre de l'événement
    2013-08-29
  • Date de publication de l'événement
    2014-01-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122398
  • 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
    Azo dye, calcium - Product Code CJY
  • Cause
    High positive calcium bias on plasma sample versus results on serum.
  • Action
    Vital Diagnostics issued a Recall Notice dated August 29, 2013, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use plasma for the determination of total calcium when using the affected product. The use of serum is acceptable, thus the product can still be used to determine total calcium with this sample type. Vital Diagnostics released a corection to the package insert for the Envoy Calcium Reagent. Customers with the affected product in their laboratory, were instructed to discard the insert packed with the product and replace it with the insert enclosed with this bulletin. If product was transferred to another location, the bulletin should be forwarded to that location. The package insert was revised indicating to only use Serum samples when running Calcium. Vital Diagnostics issued a revised (expanded) notice dated September 19, 2013, to include the Consult Diagnostics¿ Eon Calcium Reagent (PN: 1429) requesting users to discontinue using the single vial Eon Calcium kit (PN: 1429). Customers with questions were instructed to call Vital Diagnostics Technical Support at 1-855-354-8324.. For questions regarding this recall call 401-642-8400.

Device

Device Recall Consult Diagnostics Eon Calcium Reagent For InVitro Diagnostic Use
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use || PN: 1429 || For the quantitative measurement of calcium in plasma and serum
  • Manufacturer
    Vital Diagnostics, Inc.

Manufacturer

Vital Diagnostics, Inc.
  • Adresse du fabricant
    Vital Diagnostics, Inc., 27 Wellington Rd, Lincoln RI 02865-4411
  • Société-mère du fabricant (2017)
    Ergon Capital Partners
  • Source
    USFDA