Events

Rappel de Access Hybritech Free PSA

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
    61770
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1645-2012
  • Date de mise en oeuvre de l'événement
    2011-10-11
  • Date de publication de l'événement
    2012-05-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109024
  • 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
    Test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign condit - Product Code MTG
  • Cause
    A recall was initiated because beckman coulter has confirmed a change to the recommended diluents for the access hybritech free psa reagent.
  • Action
    Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed regarding a change to the recommended diluents for the Access Hybritech free PSA reagent. Patient safety is not affected by this change. " Do not dilute elevated free PSA patient samples with Wash Buffer II. " Do not dilute elevated free PSA patient samples using the UniCel DxI onboard dilution feature. " Dilute elevated free PSA samples with Access Hybritech free PSA Calibrator S0 only. " A review of historical patient results is not required because there is no effect on clinical interpretation. * The UniCel DxI onboard dilution feature is only available in limited geographies. " An updated version of the UniCel DxI Assay Protocol File (APF) will remove the Access Hybritech free PSA (dfPSA) onboard dilution assay from the list of available assays. " The Access Hybritech free PSA IFU will be updated to remove Wash Buffer II as an acceptable diluent for elevated patient samples. Correct any procedure manuals or other documents created in your laboratory that list Wash Buffer II as an acceptable diluent for the Access Hybritech free PSA assay. Please share this information with your laboratory staff. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of the letter to them. Please complete and return the enclosed response form within 10 days so we are certain you received this important communication. If you have any questions regarding this notification, please contact our Customer Support Center " Via our website, http://www.beckmancoulter.com/customersupport/support " Via phone, call 1-800-854-3633 in the United States and Canada Outside the United States and Canada, contact your local Beckman Coulter Representative. We apologize for the inconvenie

Device

Access Hybritech Free PSA
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide ) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia, Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French, Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libyan, Arab, Jamahiriya, Macao, Mexico, Moldova, Republic of Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, Emirates, United Kingdom, Uruguay ,Venezuela, Viet Nam, Yemen and Zimbabwe.
  • Description du dispositif
    Access Hybritech Free PSA, Part Number: 37210 || Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA