Alerte De Sécurité sur HbA1c Kit - Registration no. 80115310145 - Models: R1: 2 x 15 ml + R2: 1 x 10 ml + R3: 1 x 5 ml - All lots manufactured in Brazil.

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
    1134
  • Date
    2012-05-16
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    DiaSys Diagnostics Systems GmbH, Germany, forwarded the communiqué to Kovalent do Brasil Ltda., Which repacks, labels and markets the One HbA1c FS product in Brazil, stating that one of its customers observed a falsely high HbA1c value of 10, 4%, in a sample analyzed with the DiaSys brand HbA1c IS reagent (photometric analysis). As this value was unlikely, the same sample was evaluated by the HPLC method, giving a value equal to 7.5%. The investigations, to find the cause of the falsely elevated value of HbA1c when tested by photometry, resulted in the diagnosis of Severe Monoclonal Gamopathy of the patient. Gammatids are known to cause nonspecific turbidity in patient samples due to protein precipitation, and therefore interfere with photometric analysis. These are very rare cases and can not be avoided most of the time. There are no reports in the Notivisa system. Anvisa follows this action.
  • Cause
    Possibility of falsely elevated hba1c results when samples from patients with gammopathies are dosed by photometric analysis.
  • Action
    The company has already promoted the communication to its customers and made the change in the product label, emphasizing the falsification condition by samples from patients with gamma. See attached.

Manufacturer