Alerte De Sécurité sur Trade name: Etest Cefuroxima Technical name: Etest family (Etest Cefuroxima): 100 strips (foam) and individual presentation 30 strips (single pack). ANVISA Registration Number: 10158120623 Hazard Class: II Model Affected: N / A Serial Numbers Affected: Reference 412305: Lot 1004497810 / Reference 506918: Lot 1004022170.

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 Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp..

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
    2202
  • Date
    2017-02-20
  • 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
    Biomerieux will forward Letter to all clients containing all the guidelines. Recommendations for CLSI 2016 users only. Labs may continue to use the Etest Cefuroxime product (single pack and foam presentations) and may release the results for Streptococcus pneumoniae and Enterobacteriaeceae when oral cut-off points are used when applying the recommendations, as described in the Letter to the Client. For the tests previously performed, Biomérieux requests that it identify any possible false-sensitive results, analyze the related risks and determine appropriate actions, if relevant. Contact your Biomerieux representative for product compensation. Complete the Confirmation Form (Attachment A), forwarded with the Letter to the Client, and return to Biomérieux. #### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Cause
    An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for strains of relevance, including enterobacteriaceae, haemophilus and s. pneumoniae species. an additional analysis was then performed for clinical categorization of strains based on the clsi guideline. the investigation revealed a potential problem for the categorization of strains of streptococcus pneumoniae and enterobacteriaceae limited to oral cefuroxime cutoff points and based only on clinical clsi 2016 standards. for steptococcus pneumonia with etest cefuroxime foam and single pack that could lead to a minor error in clinical strains: false-sensitive result rather than intermediate results with bmd reference method (broth microdilution); false intermediate result rather than resistant result with reference method bmd (broth microdilution). for enterobacteriaceae: false-sensitive result rather than intermediate results with reference method ad (dilution in agar); false intermediate result rather than resistant results with ad (agar dilution agar) reference method. product performance is within specification when interpreted with eucast 2016 guidelines.
  • Action
    Field Action Code FSCA 3303 triggered under the responsibility of the company Biomerieux Brasil Ind Comercio de Produtos Laboratoriais Ltda. Company will update, correct or supplement the instructions for use.

Manufacturer