Events

Alerte De Sécurité sur 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.

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 BIOSYS LTDA.; DIASYS DIAGNOSTIC SYSTEMS GMBH & CO.

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
    1961
  • Date
    2016-04-19
  • 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
    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.
  • Cause
    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.
  • Action
    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