Alerta De Seguridad para Name of the product: Elecsys® Anti-HAV Technical Name: HEPATITIS A VIRUS (HAV) ANVISA Registration Number: 10287410468 Hazard Class: III Affected Model: 12542601; 13676201; 15829301; 15829302; 16,602,101; 16602102; 17969201; 18108901; 18108902; 18383501; 18383502; 18554101; 18554102; 18771301; 18771302; 17415201; 17546301; 17546302; 17703001; 17843301.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Customer / User Recommendations: - Please consider the limitations of the new section "Sample Collection and Preparation" in the Elecsys Anti-HAV Instructions for Use, as listed below: Sample Collection and Preparation Only the following samples have been tested and considered acceptable. The serum is collected in standard sample tubes or with separator gel. Plasma treated with K3-EDTA and sodium citrate. Criteria: Mean recovery between 80-120% of serum value Stability: 7 days at 2-8 ° C, 3 months at -20 ° C. Samples may be frozen 6 times. For plasma treated with lithium heparin or sodium heparin, the values ​​found were up to 35% lower than those obtained in serum. The indicated sample types were tested using selected and commercially available sample collection tubes at the time of the test, i.e., not all tubes from the different manufacturers available on the market were tested. Sample collection systems from different manufacturers may, in turn, contain different materials which, in some cases, may affect test results. When processing samples into primary tubes (sample collection systems) refer to the tube manufacturer's instructions. Frozen samples and samples containing precipitate shall be centrifuged prior to the test. - Repetition of the test: If there is suspicion of discrepant results with Li- and Na-heparin plasma samples or if there are specific questions, repeat testing may be advisable in accordance with relevant clinical information. ##### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    With this notification, roche diagnostica brasil informs its customers that the legal manufacturer, roche diagnostics gmbh, has learned that the performance of the elecsys® anti-hav assay is affected by certain types of plasma samples. for this reason, the instruction for use contained in "collection and sample preparation" for the acceptable samples will be corrected. plasma samples handled with heparin-li and heparin-na will no longer be acceptable sample types.
  • Acción
    Field Action Code SBN-CPS-2016-018 triggered under the responsibility of Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.