Events

Rappel de IMMULITE /IMMULITE 1000 Systems COR

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.

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
    69321
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0122-2015
  • Date de mise en oeuvre de l'événement
    2014-09-19
  • Date de publication de l'événement
    2014-10-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130224
  • 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, cortisol - Product Code CGR
  • Cause
    Customer complaints were received for positive bias reported on the controls used on the immulite /immulite 1000 on the cortisol assay reagent lots immulite /immulite 1000 (lkco1) lots 381,382 and 383 . subsequently, the firm confirmed a positive bias on the immulite/immulite 1000 (lkco1) lots 381, 382 and 383.
  • Action
    US Customers were sent an Urgent Medical Device Recall Letter (UMDR2014-09-19, dated 9/19/14) via FedEx on 9/19/14. Outside US Customers were sent an Urgent Field Safety Notice Letter. The letters inform the consignees of the recall of the IMMULITE/IMMULITE 1000 Cortisol (LKCO1) assay, kit lots 381, 382 and 383. Customers were asked to take the following actions: - Please review this letter with your Medical Director. - Discontinue use of and discard the IMMULITE/IMMULITE 1000 Cortisol kit lots listed in the letter. - Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice letter within thirty (30) days.

Device

IMMULITE /IMMULITE 1000 Systems COR
  • Modèle / numéro de série
    Lots: 381 (exp. 10/31/2014), 382 (exp. 10/31/2014) and 383 (exp. 11/30/2014)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and internationally to Canada.
  • Description du dispositif
    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. || For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA