Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2202
  • Date
    2017-02-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.

Device

Trade name: Etest Cefuroxima Technical name: Etest family (Etest Cefuroxima): 100 strips (foam) a...

Manufacturer

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