Events

Rappel de Estrone Radioimmunoassay (RIA) Kit

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 Beckman Coulter 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
    56399
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1685-2011
  • Date de mise en oeuvre de l'événement
    2010-04-22
  • Date de publication de l'événement
    2011-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93491
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    Estrone Radioimmunoassay - Product Code CGF
  • Cause
    Beckman coulter has confirmed that eight estrone ria kit (ref dsl 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. lots 992637, 100115a, 100205a, 100205ra, and 100226a have now expired and should not be in active use any more.
  • Action
    Beckman Coulter released an Urgent: Product Corrective Action letter dated July 9, 2010 identifying the affected product and informing consignees of the reason for recall, asking them to take the following actions: *For lots 992637, 100115A, 100205A, 100205RA, and 100226A, review historical external quality control results relevant to the patients' results obtained with these lots to ensure the assay performance was within laboratory specifications. *For lots 100319A, 100409A, 100409RA, review patents' results obtained with the results of external quality control and interpret them in the light of additional applicable tests, patient's clinical status and clinical history of patient. Beckman Coulter has finalized the process of re-adjusting Estrone calibrators' values assignment to the new internal reference calibrator starting with lot 100403A. If consignees need products for additional tests they were told to follow replacement instructions below: *In the United States, please contact Customer Service at 1-800-526-3821 *Outside the United States, contact your local Beckman Coulter Representative. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They were to also complete and return the enclosed response form within 10 days so the firm can be assured that consignees received the notification. Consignees were instructed to forward any other questions regarding the notification to the DSL Technical Support Center at 1-800-231-7970 in the United States, or contact their local Beckman Coulter Representative.

Device

Estrone Radioimmunoassay (RIA) Kit
  • Modèle / numéro de série
    Lot numbers: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada.
  • Description du dispositif
    Estrone Radioimmunoassay (RIA) Kit, DSL-8700. || Intended for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA