Events

Rappel de Device Recall Access Total T4 Reagent 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
    58169
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1949-2011
  • Date de mise en oeuvre de l'événement
    2011-03-10
  • Date de publication de l'événement
    2011-04-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98573
  • 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
    Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
  • Cause
    The recall was initiated because the concentration of total t4 in samples from pregnant women is erroneously low (20%) when measured using the access total t4 assay. erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm.
  • Action
    Beckman Coulter sent an Urgent Product Correction letter dated March 20, 2011, to all affected consignees. The letter identified the product, the problem and the action to be taken by the consignee. Consignees were issued the following instructions: (1) If you suspect pregnant patient results were evaluated at your laboratory using only Total T4 to report thyroid status, consider reviewing Total T4 results reported in the last 9 months. Consult with your Laboratory Medical Director and requesting physician to resolve any concerns you may have regarding previously reported patient results during this time period. (2) Do not use the Access Total T4 assay as the only marker for evaluating pregnant patients for thyroid disorders. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded Access Total T4 reagent kits (Part Number 33800) to another laboratory, please provide a copy of this letter to them. (4) Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. For questions regarding this notice, consignees were instructed to contact Beckman Coulter Customer Support Center. (1) Via our website, http://www.beckmancoulter.com/customersupport/support (2) Via phone, call 1-800-854-3633 in the United States and Canada (3) Outside the United States and Canada please contact your local Beckman Coulter

Device

Device Recall Access Total T4 Reagent Kit
  • Modèle / numéro de série
    Lot Numbers (s): All reagent pack lots
  • 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 Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Malaysia, Mexico, Republic of Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Philippines, Poland, Puerto Rico, Reunion, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, and Zambia
  • Description du dispositif
    Access Total T4 Reagent Kit, Part Number: 33800, || Lot Numbers (s): All reagent pack lots || The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
  • 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