Events

Rappel de Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20

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
    37334
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0722-2007
  • Date de mise en oeuvre de l'événement
    2007-01-30
  • Date de publication de l'événement
    2007-04-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50375
  • 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
    in vitro diagnostic - Product Code CEO
  • Cause
    Patient results are falsely decreased by up to 15% at these levels: 1) serum plasma phosphorus greater than 8.0 mg/dl (2.60 mmol/l) 2) urine phosphorus greater than 80.0 mg/dl (25.80 mmol/l).
  • Action
    A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.

Device

Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
  • Modèle / numéro de série
    42020HW00 & 44037HW00
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica
  • Description du dispositif
    Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

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