Events

Alerte De Sécurité sur TOTAL PROTEIN - Record in Anvisa - 80115310073 - Lots Affected: 1073671330/1073671229/1073661354/1073661352/1073661353/1085501210/1085501211/1073661249/1073671227/1073661251/1085501313/1073671228.

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 KOVALENT DO BRASIL LTDA.

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
    1238
  • Date
    2013-04-02
  • 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
    The loss of stability in the on-board situation is being investigated. Additional control measures will be defined. The risk of releasing incorrect results is considered medium to high if the instructions for use of the product are not followed. As the instructions for use are emphatic regarding the need for use of controls during the procedure, the remaining probability of incorrect results becomes low and the risk tolerable. The controls used will detect the need for re-calibration of the test before releasing the final results. In the manual procedure this loss of stability is not observed since, after use, the reagent bottles are capped and returned to the storage informed in the Instructions for Use.
  • Cause
    Loss of stability of the reagents after a few hours when in the "on board" situation, ie when left inside the rotor of automated equipment.
  • Action
    The company recommends that the use of the products be stopped immediately. Verify in your inventory the existence of the lot of the affected product, segregating it and returning it or destroying it, according to the institution's procedures and those recommended by the manufacturer.

Device

TOTAL PROTEIN - Record in Anvisa - 80115310073 - Lots Affected: 1073671330/1073671229/1073661354/...

Manufacturer

KOVALENT DO BRASIL LTDA