Events

Rappel de Access Total BhCG (BhCG) Assay

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
    57443
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1736-2011
  • Date de mise en oeuvre de l'événement
    2010-10-20
  • Date de publication de l'événement
    2011-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96242
  • 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
    Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
  • Cause
    Beckman coulter has confirmed that non-reproducible falsely elevated test results may occur when using the access total bhcg assay. these elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range. the role of preanalytical factors in laboratory testing has been described in a variety of published literature.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action letter dated November 11, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:. " Evaluate current laboratory protocols to ensure the necessary procedures are in place for identifying and mitigating falsely elevated test results. " Follow the sample handling instructions provided in the Access Total ¿hCG Instruction for Use (IFU). " Review the enclosed pre-analytical sample handling information bulletins: 1. The Role of Preanalytical Factors in Chemistry and Immunoassay Testing (P/N A34880A). 2. Sample Handling Makes a Difference (P/N A28226A). " At the discretion of the laboratory director, any total ¿hCG result that is questioned due to lack of clinical correlation should be repeated. NOTE: Due to the clinical utility of the Access Total ¿hCG assay as a biomarker of pregnancy, Beckman Coulter feels it is unnecessary to require a review of all previously obtained Access Total ¿hCG test results. The Access Total ¿hCG assay is intended as a marker for pregnancy at the time of testing. A discrepant or questionable result would have been brought to the attention of the laboratory. The pregnancy status of a patient at this point, post testing, would be known to the patient and the physician. " Please share this information with your laboratory staff and your phlebotomy director and/or phlebotomy staff and retain this notification as part of your laboratory Quality System documentation. " Complete and return the enclosed response form within ten days so they can be assured that this important notification has been received. If you have any questions regarding this notification, please contact the Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada

Device

Access Total BhCG (BhCG) Assay
  • Modèle / numéro de série
    All lot numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Congo, Croatia, Czech Republic, Djibouti, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Zambia, Zimbabwe.
  • Description du dispositif
    Access Total BhCG (BhCG) Assay Part Number 33500 || The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG 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