Events

Rappel de Device Recall ADVIA 1200 Chemistry System

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 Bayer Healthcare, LLC (Diagnostics Division).

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
    35880
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1449-06
  • Date de mise en oeuvre de l'événement
    2006-02-17
  • Date de publication de l'événement
    2006-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47084
  • 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
    Automated Clinical Chemistry Analyzer - Product Code JGS
  • Cause
    Low qc recovery observed on carbamazepine (carb) results immediately following a gentamicin (gent) assay or a digoxin (dig) assay. when gent or dig precedes carb, the carb test result is artificially low (as much as -25%). phny was determined to also exhibit a similar carryover effect on carb. all others were found not to produce the same reagent probe-based carryover effect.
  • Action
    Bayer HealthCare LLC issued a Support Bulletin to all affected Bayer HealthCare LLC Branches on/about 2/17/06 in order to inform them of the issue and to provide them with instructions for this ''field correction''. Customer Bulletins were also issued to the Branches both in the United States and elsewhere for communication with the affected customers.

Device

Device Recall ADVIA 1200 Chemistry System
  • Modèle / numéro de série
    Part No. 094-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide including USA and Puerto Rico.
  • Description du dispositif
    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)

Manufacturer

Bayer Healthcare, LLC (Diagnostics Division)
  • Adresse du fabricant
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
  • Source
    USFDA