Events

Rappel de Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer

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 Laboratories.

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
    46368
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1165-2008
  • Date de mise en oeuvre de l'événement
    2008-01-15
  • Date de publication de l'événement
    2008-04-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67306
  • 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
    Differential Cell Counter - Product Code GKZ
  • Cause
    Count may be out of specification--hemoglobin background count may be out of specification (high) after installation of new cell-dyn sapphire hemoglobin reagent syringes with packaging dates between may 8, 2007 and november 29, 2007.
  • Action
    On January 11, 2008, an Urgent Product Recall Letter and Customer Reply Form were sent to all currently active CELL-DYN Sapphire customers (end-users). The firm provided information for verification of replacement syringes and instructions if hemoglobin background is not within specification. A second Urgent Product Recall letter was sent on January 15, 2008. If this second Customer Reply Form is not faxed back to Abbott, customers will be contacted via an approved telephone protocol. For further information contact customer support at 1-877-4ABBOTT.

Device

Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer
  • Modèle / numéro de série
    All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8,2007 and November 29,2007. Each package is identified with product description "CDS HGB SRNG W/BU".
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.
  • Description du dispositif
    CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Adresse du fabricant
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA