Events

Rappel de Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly

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 Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA.

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
    56775
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0489-2011
  • Date de mise en oeuvre de l'événement
    2010-07-23
  • Date de publication de l'événement
    2010-11-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94516
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    The vent needle, which is built into the vent head assembly on the cell-dyn sapphire instrument and which is used directly on the cell-dyn 4000 instrument, may be defective, which may result in an undetected short sample, generating incorrect low results, or which may bend, preventing aspiration of the sample.
  • Action
    Abbott Laboratories issued a Product Recall letter dated July 23, 2010 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were instructed to discard all affected vent needles and replace them with the needle included with the recall letter. Customers may contact customer support at 1-877-422-2688 concerning this recall.

Device

Device Recall CellDyn 4000 and CellDyn Sapphire Vent Needle head assembly
  • Modèle / numéro de série
    Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
  • Description du dispositif
    CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; || CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, || CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, || CELL-DYN 4000 Vent Needle, List Number: 02H61-01, || CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, || CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, || CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, || CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; || Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
  • Manufacturer
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

Manufacturer

Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Adresse du fabricant
    Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA