Events

Rappel de AutoCheck5

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 Radiometer America 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
    78097
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3237-2017
  • Date de mise en oeuvre de l'événement
    2017-09-07
  • 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=158651
  • 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
    Controls for blood-gases, (assayed and unassayed) - Product Code JJS
  • Cause
    Radiometer has recently become aware that a few of the autocheck 5+ level 2 ampoules, will give incorrect results for pco2 and po2. a defective qc ampoule will for: " pco2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kpa or 36.9  46.9 mmhg) " po2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kpa (104-107 mmhg).
  • Action
    Radiometer sent a Safety Notice dated September 7, 2017, to all affected customers. The firm initiated their recall on 09/07/2017 by email. The letter requested the following: 1. Please check your inventory and analyzers for any boxes and ampoules of above mentioned QC. 2. Discard all Boxes and ampoules of this lot. 3. Complete the response form and return it to the number on the form. Please note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-user. Customers with questions were advised to contact their Radiometer representative.

Device

AutoCheck5
  • Modèle / numéro de série
    S7745 Lot R0698
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.
  • Description du dispositif
    AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers || The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Adresse du fabricant
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA