Events

Rappel de Device Recall AEROSET, ARCHITECTURE C8000 & C16000

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 Inc..

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
    55700
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2398-2010
  • Date de mise en oeuvre de l'événement
    2010-05-04
  • Date de publication de l'événement
    2010-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91601
  • 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
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • Cause
    Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
  • Action
    Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT cSystems, implement alternative kit sizes without system changes. 7) Provide a copy of the letter to other laboratories that have been distributed the affected product. US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.

Device

Device Recall AEROSET, ARCHITECTURE C8000 & C16000
  • Modèle / numéro de série
    Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21).
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.
  • Description du dispositif
    Clinical Chemistry Phosphorus assay
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

Abbott Laboratories Inc.
  • Adresse du fabricant
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA