Events

Rappel de Access Immunoassay Systems

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
    57450
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1935-2011
  • Date de mise en oeuvre de l'événement
    2010-10-05
  • 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
    2012-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96267
  • 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
    Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
  • Cause
    The recall was initiated because beckman coulter confirmed access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. over time, waste bottles can degrade, become brittle and potentially crack.
  • Action
    The recall communication was initiated on October 5, 2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access immunoassay Systems, UniCel DxC 600i Access, and Immunoassay Systems, Synchron LxI 725 Access Clinical Systems. The letter explains the problem identified, the impact, and actions required to be taken by customers. The letter instructs customers to inspect the waste bottle for signs of aging and deterioration. New bottles are opaque white in color. Signs of deterioration include: o Any color change to the bottle (yellow, orange or pink) o Cracking o Crazing (spider web cracking) Any defect that is not removed by routine cleaning is a sign of deterioration. It is important to routinely inspect the area nearest the handle and along all seams of the bottle. If upon inspection consignees detect any issues with their waste bottles, they were asked to contact Beckman Coulter Customer Service using the enclosed Replacement Order Form to obtain a new waste bottle, and keep this information should they require a replacement bottle in the future. Consignees were also asked to share this information with laboratory staff and retain the notification as part of laboratory Quality System documentation. They should also complete and return the enclosed Product Corrective Action Response Form within 10 days so Beckman Coulter can be certain they received this important notification. Beckman Coulter offers a service kit which may be used to replace the waste bottle and direct liquid waste to a floor drain. Beckman Coulter requires a consultation with consignees technical support representative to determine if their system can be fitted with a floor drain kit. If assistance is needed or consignees have any questions regarding this notification, they were asked to contact Technical Support at 1-800-854-3633 i

Device

Access Immunoassay Systems
  • Modèle / numéro de série
    All Serial Numbers.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.
  • Description du dispositif
    Access Immunoassay Systems, Part Number 81600N & 81600N. || An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.
  • 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