Events

Rappel de CELLDYN Emerald

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
    57202
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1094-2011
  • Date de mise en oeuvre de l'événement
    2010-10-15
  • Date de publication de l'événement
    2011-02-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95590
  • 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
    There is the potential for the instrument to not power up due to the flash memory issue. this will result in an error message displayed is "no memory available" and has the potential for delay in generating patient results.
  • Action
    The firm, Abbott Laboratories, sent a "Product Correction" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.

Device

CELLDYN Emerald
  • Modèle / numéro de série
    Serial numbers ending in  0063,0110,0196,0197,  0230,0281,0285,0293,  0319,0329,0332,0358,  0361,0362,0396,0435,  0440,0468,0474,0606,  0642, 0664, 0687, and  0719 through 1331
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI; and countries including: Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago.
  • Description du dispositif
    Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; || List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; || Product is distributed by || Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL || Intended use: The CELL-DYN Emerald 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