Events

Rappel de Beckman Coulter Access Immunoassay System CEA

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
    35630
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1313-06
  • Date de mise en oeuvre de l'événement
    2006-04-12
  • Date de publication de l'événement
    2006-08-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46516
  • 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
    in vitro diagnostic - Product Code DHX
  • Cause
    Firm has confirmed that the access cea assay may generate decreased values with certain frozen platelet specimens.
  • Action
    A Product Corrective Action letter was sent via US mail the week of April 10, 2006 to all Access CEA customers informing them that the Access CEA Assay could generate decreased values with certain frozen patient specimens. Although they have found it at a low occurrence, it is recommended that specimens should not be frozen prior to analysis until further notice. The letter informs customers that Beckman Coulter has verified sample stability through at least 14 days when properly stored at 2-8 degrees Celsius and shipping stability for 4 days at 2-8 degrees Celsius using cool packs. Firm also advises customers to contact customer technical support or local Beckman Coulter Representative if laboratory is unable to avoid freezing specimens and to review results from frozen CEA samples to ensure that the match the total clinical presentation per the customer''s established laboratory procedure. The letter requests that the notification remain part of the laboratory Quality System documentation and that the response form be returned to the firm within 10 days.

Device

Beckman Coulter Access Immunoassay System CEA
  • Modèle / numéro de série
    All codes
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Canada
  • Description du dispositif
    Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Adresse du fabricant
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA