Events

Rappel de Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent

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
    66396
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0365-2014
  • Date de publication de l'événement
    2013-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122248
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • Cause
    Siemens healthcare diagnostics is conducting a field correction for siemens chemistry calibrator lots 090445b and 090445c on the advia 1200, 1650, 1800, and 2400 chemistry systems. the system specific values (ssvs) for the direct bilirubin assay (dbil_2) have been reassigned for these lots. siemens has determined that the dbil_2 ssvs currently assigned to these lots may cause an average shift of.
  • Action
    Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction Letters dated September 24, 2013 and Response Forms to the US consignees via FedEx. Urgent Field Safety Notices were also distributed to customers outside the US. Customers are instructed to use the reassigned System Specific Values for the affected lots listed in the letter. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within thirty (30) days. The questionnaire is to be faxed to the Technical Solutions Center at 302-631-7597. On September 30, 2013, Siemens sent a revised customer notifications to correct the Part Number.

Device

Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent
  • Modèle / numéro de série
    Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.
  • Description du dispositif
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD || Product usage: Usage: || DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

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