Events

Rappel de Stat Profile Critical Care Xpress (CCX and CCX)

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 Nova Biomedical Corporation.

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
    49127
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1328-2009
  • Date de mise en oeuvre de l'événement
    2008-08-11
  • Date de publication de l'événement
    2009-05-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72815
  • 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
    Ion Based Enzymatic Creatine Electrode - Product Code CGL
  • Cause
    Erroneous, low creatinine results on ccx analyzer.
  • Action
    Initial: USA and Canada - Customer Advisory Notice notification by phone contact with key customer contact facilitated using a Field Correction Script. This contact will be documented within the Nova Biomedical Technical Support database (Pivotal) and on a Field Correction Checklist. All affected inventory will be replaced at customer sites. International - Customer Advisory Notice and Faxback Form being communicated and sent to Nova Biomedical Subsidiaries and Distributors by three methods of delivery (Email, Fax and Phone Call). Follow-up: USA and Canada - Sending the Customer Advisory Notice by email and/or fax to the key customer contact from the initial phone contact. International - Sending the Customer Advisory Notice by email and/or fax to the key contact.

Device

Stat Profile Critical Care Xpress (CCX and CCX)
  • Modèle / numéro de série
    Lots 806050, 806182, 806242, 806567, 806721, 806752, and 807246.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.
  • Description du dispositif
    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer || Catalog # 35238 || Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • Adresse du fabricant
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453-3457
  • Société-mère du fabricant (2017)
    Nova Biomedical Corporation
  • Source
    USFDA