Events

Alerte De Sécurité sur FAMILY ESTER, Brand: Biomerieux, Model: piperacillin / tazobactam - 30 and 100 strips (in blister pack); piperacillin / tazobactam - 30 and 100 strips (in foam cartridge). piperacillin / tazobactam - 30 individual strips (in single pack). Record: 10158120623, Reference 412431: Lots: 1004331500; 1004271120; 1003415090; 1003276060; 1003069230; 1002488490; 1001936360; Reference 521418 Lots: 1004276460; 1004180840; 1003980200; 1003416920; 1002995820; 1002482640; 1002375410; 1002276210; 1002092270

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 Biomerieux Brasil S.A.; Biomerieux S.A..

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
    1768
  • Date
    2015-12-07
  • 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 the risk to the patient, with the change in performance with Etest Piperacillin / Tazobactam, is the potential error in releasing incorrect results for this antibiotic, mainly in relation to false sensitivity. This risk can lead to medical intervention for the patient, because this incorrect result may negatively influence the choice of appropriate therapy.
  • Cause
    Reporting of low mic value. increased incorrect results, false sensitivity results, when compared with reference test (broth microdilution). an investigation has begun to confirm the performance of the product and to determine the root cause.
  • Action
    Collection, destruction of the product and blocking of marketing. The company will forward Letter to all customers who have purchased the product and instruct them to discontinue use and remove affected lots. The company will replace the kits. It is important to pass the alert to all the professionals of the laboratories that work with this product. Action code: 2709.

Device

FAMILY ESTER, Brand: Biomerieux, Model: piperacillin / tazobactam - 30 and 100 strips (in blister...

Manufacturer

Biomerieux Brasil S.A.; Biomerieux S.A.