Events

Rappel de Advia Chemistry Systems Calibrator

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
    75487
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0589-2017
  • Date de mise en oeuvre de l'événement
    2016-10-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150481
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Cause
    Siemens has confirmed that the dbil_2 assigned calibrator values (acv) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement.
  • Action
    Siemens issued an Urgent Medical Device Correction in the US and an Urgent Field Safety Notice Outside the US beginning on October 6, 2016. Customers were notified of the issue and instructed to use the reassigned DBIL_2 calibrator value for Chemistry Calibrator Lot Numbers 680726, 680726A, 680726B, 680726C and 680726D. Customers were also requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days by faxing to the Customer Care Center at 312-275-7795. For questions regarding this recall call 914-631-8000.

Device

Advia Chemistry Systems Calibrator
  • Modèle / numéro de série
    Device Listing # D033650 Model# SMN# 10312279 Lot Numbers: 680726, 680726A, 680726B, 680726C, 680726D
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Internationally to Canada, Mexico, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, Cyprus, Denmark, Egypt, Ecuador, Finland, France, Germany, Great Britain, Hong Kong, Hungary, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Poland, Portugal, Russian Fed. Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, Vatican City and Vietnam
  • Description du dispositif
    Advia Chemistry Calibrator || For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c)
  • 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