Events

Alerte De Sécurité sur Trade name: 31 Vitros Calibrator Kit. Registration number ANVISA: 80145901715. Technical Name: Glycated hemoglobin. Risk class: Product classified as II and the control of these systems is performed by lot number. Affected model: 119 calibration kit units have been imported that together with the Assay Data Diskette (ADD) versions 5873, 5874, 5875 and 5876 will not be possible to calibrate

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC.

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
    1926
  • Date
    2016-05-19
  • 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
    According to the company, users who own the batch affected by this field action should: • Install the DRV 5877 Assay Data Diskette or later on their VITROS System. After successful calibration and quality control evaluation, it is acceptable to use the VITROS Reagent Kit for HbA1c, GEN 06. NOTE: For electronically connected systems, automatic download was available as of April 12, 2016.
  • Cause
    Impossibility to calibrate the vitros® chemistry products reagent kit for hba1c, generation (gen) 06, when using the vitros calibrator kit, lot 3155 and specific assay data diskettes (5873, 5874, 5875 and 5876). it should be noted that the assay data diskette (add) drv 5877 and later contain the correct calibration data. ortho clinical diagnostics (ortho) has detected an incorrect value (calibration data / mathematics) in the adds listed above for the vitros 31 calibrator kit, lot 3155, used to support the vitros reagent kit for hba1c, gen 06. the value incorrect calibration will prevent successful calibration of the test.
  • Action
    Action required for laboratories that have the affected lot: • Install the Assay Data Diskette DRV 5877 or later on your VITROS System. After successful calibration and quality control evaluation, it is acceptable to use the VITROS Reagent Kit for HbA1c, GEN 06. NOTE: For electronically connected systems, automatic downloading has been available since April 12, 2016. This is a situation where the use of the product is not likely to cause adverse health consequences. Cod. 16000096 - Letter to clients in ANNEX

Device

Trade name: 31 Vitros Calibrator Kit. Registration number ANVISA: 80145901715. Technical Name: Gl...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC