Events

Alerta De Seguridad para TruLab N (Anvisa registration number: 10350840060), TruLab P (Anvisa registration number: 10350840064), Trulab Protein (Anvisa registration number: 10350840091), TruLab Urine Level 2 (Anvisa registration number: 10350840237) Trulab N: 6x5 ml / Trulab P: 6x5ml / Trulab PROTEIN: 3x1ml / Trulab Urine: TruCal U (Registration number Anvisa: 10350840059) /// Record number: 80511919003 /// Affect: 20x5ml / Trucal U: 20x3ml /// lots affected: TruLab N: 20270; TruLab Urine Level 2: 20542; TruCal U: 20695 / / Product hazard class: III.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOSYS LTDA.; DIASYS DIAGNOSTIC SYSTEMS GMBH & CO.

¿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
    1961
  • Fecha
    2016-04-19
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Impact on client outcomes: When using Trulab controls: no impact is observed on patient outcomes, as the variation observed in the parameters is considered insignificant. When using the Trucal U calibrator, lot 20695, whose calibration value for AST / GPT changes from 105 U / L to 99.8 U / L, thus occurring a variation of -5%, it will happen that when using this new value of patient outcomes will also be diverted / changed by -5%. ### UPDATED ON 09/27/2017, the company sent the company presented information of the field action proving the sending of the safety notice to the client and terminating the field action.
  • Causa
    Biosys ltda, who registered the referenced products, received a report from the international manufacturer of these products, diasys diagnostic systems gmbh, stating that the internal measurements carried out by the quality assurance showed that target values ​​of some parameters of the trulab n, trulab p, trulab protein, trulab urine and trucal u-universal calibrator had to be redesignated following the parameters that were re-assigned by product: a) in trulab n and trulab p: alkaline phosphatase, alt / gpt, total bilirubin, chloride, ck, gldh , glucose, igm and lipase. b) in trulab protein: myoglobin, c-reactive preotein. c) in trulab urine level 2: creatinine. d) in ​​trucal u: ast / got. biosys informs that it has not.
  • Acción
    Classification of risk: II /// Classification of the field action: correction in the field /// Field action code: 2832 /// Recommendations to users and patients: replace the previously reported target values ​​with the new target values ​​reported in Informative letter sent via email. And they are informed that the updated values ​​of target value can also be obtained through the link: http://www.diasys-diagnostics.com/service-area/value-sheets/.

Device

TruLab N (Anvisa registration number: 10350840060), TruLab P (Anvisa registration number: 1035084...

Manufacturer

BIOSYS LTDA.; DIASYS DIAGNOSTIC SYSTEMS GMBH & CO
  • Source
    ANVSANVISA