Events

Rappel de Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin

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
    76770
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2166-2017
  • Date de mise en oeuvre de l'événement
    2017-01-31
  • Date de publication de l'événement
    2017-04-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154134
  • 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, testosterones and dihydrotestosterone - Product Code CDZ
  • Cause
    Certain lots of sex hormone binding globulin (shbg) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8¿c, as published in the instructions for use (ifu). adjustors stored at 2-8c after 14 days may show a bias in patient samples and quality control falling outside of published ranges. lookback not recommended.
  • Action
    Siemens issued an Urgent Medical Device Correction (UMDC) to customers using the affected SHBG adjustor lots. Customers were advised to store the affected reconstituted adjustor lots at 2-8C or -20C for up to 14 days, after which they must be discarded. The IMMULITE/IMMULITE 1000 SHBG is not affected by this issue. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 914-631-8000.

Device

Device Recall IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding Globulin
  • Modèle / numéro de série
    Lot Numbers: 1) 357, 2) 358, 3) 360, 4) 361 & 5) 363  Expiration Dates: 1) 2017-01-30, 2) 2017-03-31, 3) 2017-04-30, 4) 2017-05-31 & 5) 2017-06-30
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    SHBG IMMULITE 2000/IMMULITE 2000 XPi || For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
  • 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