Events

Rappel de Device Recall ADVIA Centaur TSH3Ultra

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
    79496
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2054-2018
  • Date de mise en oeuvre de l'événement
    2017-12-18
  • 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=162477
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Cause
    In certain scenarios the advia centaur cp, xp and xpt immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with multi-diluent 15 and certain lots of bnp and tsh3rul assays.
  • Action
    Consignees are asked to return the response form and follow the instructions pertaining to their system and assays: Actions for ALL ADVIA Centaur Systems: Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected kits are present on the system. Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. Actions for ADVIA Centaur XPT system: If you intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, you must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. Please perform the attached steps to restart the workstation. Actions for ADVIA Centaur CP system: If any of the affected kit lots have been in use on the system, you must manually track the time that the Multi-Diluent 15 has been in use on board the system. Replace the ancillary pack of Multi-Diluent 15 every 7 days when used, until a follow-up communication is received from Siemens stating this issue has been resolved.

Device

Device Recall ADVIA Centaur TSH3Ultra
  • Modèle / numéro de série
    Lot Numbers ending in: 298 and 301
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Israel Italy¿¿¿¿¿¿¿¿¿¿ Japan Latvia¿¿¿¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Netherlands¿¿¿¿ New Zealand Norway¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿
  • Description du dispositif
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA