Events

Rappel de Device Recall ABL80 FLEX COOX analyzer

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 Sendx Medical 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
    63368
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0195-2013
  • Date de mise en oeuvre de l'événement
    2010-01-06
  • Date de publication de l'événement
    2012-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113592
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    The recall was initiated because sendx medical inc. became aware of a software issue in the abl80 flex co-ox analyzer related to the reporting of the hemoglobin fractional parameters.
  • Action
    SenDx Medical sent a recall letter to all their foreign customers on January 6, 2010, to informed them of the ABL80 FLEX CO-OX recall via the Radiometer Field Action Notification (FAN) system. The Field Action Notes informed the customers of the problem identified and the action to be taken. Customers were instructed to submit confirmation fax#1 to confirm that the customer letter has been distributed to all ABL80 CO-OX customers by January 31, 2010. Customers were instructed to submit confirmation fax #2 to confirm that all ABL80 CO-OX analyzers have been upgraded to version 1.35 by 6/30/10. In the U.S., the customer was provided with a software upgrade CD along with a letter advising them to the issues associated with the recall. Customers with questions were instructed to contact TechLine at (800) 736-0600 opt 2.

Device

Device Recall ABL80 FLEX COOX analyzer
  • Modèle / numéro de série
    Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.
  • Description du dispositif
    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). || The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Adresse du fabricant
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA