Events

Rappel de Device Recall ADVIA Chemistry Triglyceride_2 concentrated

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
    73635
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1670-2016
  • Date de mise en oeuvre de l'événement
    2016-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144641
  • 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
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Cause
    Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
  • Action
    Siemens mailed an Urgent Field Safety Notice, dated March 2016, to customers confirming the ADVIA Triglyceride concentrated reagent (TRIG_c) does not meet Instructions for Use (IFU) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932. Siemens asked customers to discontinue use of and discard kits from the two referenced lots, complete and return the Field Correction Effectiveness Check attached to the letter within 30 days. Customers were to review their inventory to determine their laboratory 's replacement needs. Customers are asked to retain the letter for their records and forward a copy to anyone that received the product. Customers may contact Siemens Customers Service or their local technical support.

Device

Device Recall ADVIA Chemistry Triglyceride_2 concentrated
  • Modèle / numéro de série
    Kit lots 348297 & 359932.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.
  • Description du dispositif
    ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. || For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
  • 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