Events

Rappel de Device Recall ADVIA Centaur CA199 Assay

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 Siemens Healthcare Diagnostics, 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
    60502
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0489-2012
  • Date de mise en oeuvre de l'événement
    2011-11-11
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105596
  • 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
    System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
  • Cause
    Positive bias of 14% and higher for some individual points for ca 19-9 results generated on the advia centaur cp system when they are compared to ca 19-9 assay results generated on either the advia centaur or advia centaur xp systems.
  • Action
    Siemens Healthcare Diagnostics issued a Urgent Device Notification email dated November 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers conduct a look back if they are using the ADVIA Centaur CA 19-9 interchangeably with the ADVIA Centaur or ADVIA Centaur XP systems and the ADVIA Centaur CP system and to review the contents of the recall notice with their Laboratory Director. A confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action For further questions please call (508) 359.3825.

Device

Device Recall ADVIA Centaur CA199 Assay
  • Modèle / numéro de série
    Reagent Lot # Expiry Date XXXXX294 11-Aug-11 XXXXX296 6-Oct-11 XXXXX298 6-Nov-11 XXXXX299 6-Nov-11 XXXXX302 9-Jan-12 XXXXX303 9-Jan-12 XXXXX305 18-Feb-12 XXXXX306 3-Apr-12 XXXXX307 3-Apr-12 XXXXX308 3-Apr-12 XXXXX309 3-Jun-12 XXXXX311 30-Jun-12
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Australia, Malyasia, Korea, Hong Kong, Singapore, Myanmar, Mexico, Egypt, Taiwan, South Africa, Brazil ,India, Japan, Argentina, Chile, Peru, Germany, Malaysia, Saudi Arabia, and Canada.
  • Description du dispositif
    ADVIA Centaur CA19-9 Assay || Cat. Nos. || 123521 (03481938) - 250 Test kit w/o Calibrators || 123519 (04612750) - 50 Test kit w/o Calibrators || 10491244 - 250 Test kit w/Calibrators || 10491379 - 50 Test kit w/Calibrators || The ADVIA Centaur CA 19-9 Assay is an¿ in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA