Events

Rappel de Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent

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
    56416
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0431-2011
  • Date de mise en oeuvre de l'événement
    2010-07-26
  • Date de publication de l'événement
    2010-11-22
  • 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=93597
  • 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
    Radio immunoassay, tetosterone and dihydrotestosterone - Product Code CDZ
  • Cause
    The recall was initiated because the instruction for use (ifu) for access shbg does not specify the units of measure to be used when calculating the free androgen index (fai %). access shbg (nmol/l) values and access testosterone (ng/ml) values are reported in different default units. the testosterone value (when reported in ng/ml) requires conversion to nmol/l before the fai % can be calculated.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter on the week of July 26, 2010 to the affected customers. The letter was dated July 30, 2010, and identified the product, the problem and provided the appropriate equation to recalculate the FAI% values. The customers were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were also asked to complete and return the enclosed response form within 10 days to confirm that they had received the important notification. The customers were instructed to contact Beckman Coulter Technical Support at 1-800-854-3633 in the United States, or contact their local Beckman Coulter Representative if they had any questions regarding the notification.

Device

Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent
  • Modèle / numéro de série
    Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628,  917613, 919184
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada
  • Description du dispositif
    Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 || The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
  • 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