Events

Rappel de Device Recall Assay for CA 27.29

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
    76766
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1748-2017
  • Date de mise en oeuvre de l'événement
    2017-03-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154128
  • 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, immunological, antigen, tumor - Product Code MOI
  • Cause
    Potential for the advia centaur syphilis assay to interfere with the br (ca 27.29) a assay on the advia centaur systems.
  • Action
    Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to customers in the United States on March 08, 2017 to be delivered to customers on March 09, 2017and (UFSN) was sent for distribution to customers outside the United States on March 08, 2017. These notices inform customers of the potential and mitigation action to be taken for the ADVIA Centaur¿ Syphilis assay to interfere with the BR (CA 27.29) assay on the ADVIA Centaur Systems. This issue affects all current and future lots of ADVIA Centaur¿ Systems BR reagents until a solution is implemented. Fax-back forms included with letter used to confirm that the customers received the Urgent Medical Device Correction to the Customer Care Center at 312-275-7795. For questions regarding this recall call 508-668-5000. .

Device

Device Recall Assay for CA 27.29
  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
  • Description du dispositif
    Siemens ADVIA Centaur BR assay || Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) || BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
  • 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