Events

Rappel de Device Recall AxSYM Digoxin III Reagent Pack

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 Diagnostic International, Ltd..

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
    39416
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0064-2008
  • Date de mise en oeuvre de l'événement
    2007-07-20
  • Date de publication de l'événement
    2007-11-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55496
  • 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
    Digoxin Enzyme Immunoassay - Product Code KXT
  • Cause
    Incorrect results -- error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the axsym digoxin iii assay, rather than a concentration, is reported for the patient sample.
  • Action
    Abbott Diagnostics International Limited, Ltd., mailed a Product Correction Letter to customers on 7/20/02 advising an additional option(s) has been identified to resolve Error Codes: - Perform one of the two options to resolve these error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay. - Dilute the sample one to one (1 part sample plus 1 part Calibrator A) and repeat analysis. - The final concentration is equal to the reported concentration of the sample multiplied by the dilution factor - The minimum final concentration that may be reported out is 0.6 ng/mL, which corresponds to the sensitivity of the AxSYM Digoxin III assay (0.3 ng/mL) multiplied by the dilution factor (2). OR - Centrifuge the sample at 8,000 to 10,000 RCF for 10 minutes and repeat analysis.

Device

Device Recall AxSYM Digoxin III Reagent Pack
  • Modèle / numéro de série
    Lot # 46181Q100 Exp.Date 08/10/07, Lot # 50267Q100 Exp.Date 12/16/07
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA including States of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NY, NC, OH, OK, OR, PA, SD, SC, TN, TX, UT, VA, VT, WA, WI, WY, HI, Puerto Rico, and countries of Canada, Venezuela, Uruguay, Germany, Hong Kong, South Korea, Australia, and New Zealand
  • Description du dispositif
    Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA