Events

Alerte De Sécurité sur Trade name: IMMULITE / IMULLITE 1000 CMV IgM; IMMULITE 2000 / IMMULITE 2000 XPi CMR IgM Technical Name: IMMULITE / IMULLITE 1000 CMV IgM; IMMULITE 2000 / IMMULITE 2000 XPi CMR IgM Registration number ANVISA: 10345161051; Affected batch / series numbers: IMMULITE / IMMULITE 1000 CMV IgM Lots: 330,331 IMMULITE 2000 CMV IgM Lots: 255; 256; 257; 258; 259; 260; 261; 262; 263; 264; 266.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A,; Siemens Healthcare Diagnostics Products Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2094
  • Date
    2016-09-30
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Siemens recommends the transition to kit lot 0332 and above for CMMI IgM IMMULITE / IMMULITE 1000 and kit lots 268 and above for CMMI IgM IMMULITE 2000/2000 XPi. A revision, including retesting samples that are still in the storage time conditions specified in the Usage Instruction, is recommended for non-reactive results = 0.47 to <0.9 previously generated. Retesting using CMV IgM or another appropriate CMV assay should be considered, will depend on the clinical context and the time of the initial test performed.
  • Cause
    Siemens healthcare diagnostics has confirmed an increase in inaccuracy in some patients with lots of cmv igm reagents for the mmulite / immulite 1000 and immulite 2000 / immulite 2000 xpi systems. these samples may exhibit a high percentage of coefficient of variation (% cv) when compared to the precision performance data published in the instruction of use, through the indices of non reactive, indeterminate and reactive.
  • Action
    Field Action Code BMI 16-22 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: IMMULITE / IMULLITE 1000 CMV IgM; IMMULITE 2000 / IMMULITE 2000 XPi CMR IgM Technical...

Manufacturer

Siemens Healthcare Diagnósticos S.A,; Siemens Healthcare Diagnostics Products Ltd
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA