Events

Rappel de Device Recall ARCHITECT B12 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 MPG.

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
    34923
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0860-06
  • Date de mise en oeuvre de l'événement
    2006-03-08
  • Date de publication de l'événement
    2006-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-07-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44954
  • 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
    Radioassay, Intrinsic Factor Blocking Antibody - Product Code LIG
  • Cause
    The 30-day onboard storage information is not included in the barcode labels for these two lots. as a result, the architect system software is unable to track how long a reagent kit has been stored onboard the architect instrument.
  • Action
    Abbott affiliates in Canada, Germany and Australia were e-mailed copies of the recall letter on 3/8/06 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised that the 30-day onboard storage information is not included in the barcode for the two lots. As a result the ARCHITECT system software is unable to track how long the reagent kit has been stored onboard. The accounts were instructed to manually track the onboard storage time for the two lots, and discard the kits after 30 days of onboard storage.

Device

Device Recall ARCHITECT B12 Reagent
  • Modèle / numéro de série
    lot numbers 33079M200, 33079M201
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Canada, Germany and Australia
  • Description du dispositif
    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories MPG

Manufacturer

Abbott Laboratories MPG
  • Adresse du fabricant
    Abbott Laboratories MPG, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Source
    USFDA