Events

Rappel de CELLDYN Emerald Diluent Reagent

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
    56968
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1668-2011
  • Date de publication de l'événement
    2011-03-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95077
  • 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
    The product bar code label, when scanned, indicates that the volume is 10 ml rather than the correct volume of 10,000 ml. analytical results are not impacted, although, there is a potential for delay in generating results.
  • Action
    Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.

Device

CELLDYN Emerald Diluent Reagent
  • Modèle / numéro de série
    Lot Number: 4350, Expiration Date: June 30, 2012
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.
  • Description du dispositif
    Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, || Product is manufactured and distributed by || Abbott Diagnostics Division, Santa Clara. CA || Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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