Events

Alerte De Sécurité sur CREATININA - Registered in Anvisa under the number 80115310057 - Lots: 1073230945 (Creatinine R1 2x200ml + R2 1x100ml + 1x3ml Standard) and 1070890942 (Creatinine R1 1x200ml + R2 1x50ml + 1x3ml Standard) - Kovalent do Brasil Ltda.

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
    972
  • Date
    2009-07-24
  • 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
    It is important to note that clinical laboratories use controls capable of identifying this type of quality deviation, since changes in creatinine levels may indicate renal impairment. By means of the traceability of the affected lots, the communication was made to the customers (see annex), informing them of the fact. The process of collecting the lots is already underway and Anvisa follows the process. ### The company informed the closing of the field action through file 842387 / 09-3 of 10/27/2009.
  • Cause
    By means of studies carried out by the manufacturer, the loss of stability in a specific lot of the raw material dissodiohydrogen-phosphate, causing a decrease of stability in the creatine reagent, has been identified, being able to lead to falsely low results.
  • Action
    The actions recommended to users of the product are as follows: (1) Immediate discontinuation of use and segregation of the affected product set forth in this notice; (2) Contact your dealer or distributor (see attached list)

Device

CREATININA - Registered in Anvisa under the number 80115310057 - Lots: 1073230945 (Creatinine R1 ...

Manufacturer

Kovalent do Brasil Ltda.