Events

Safety Alert for Etest Ciprofloxacin, Etest Ciprofloxacin, Etest Vancomycin, Etest Vanipycin, Etest Benzyl Penicillin, Etest Fosfomycin, Etest Imipenem, Etest Gentamycin, Etest Tobramycin, Etest Ceftriaxone Technical Name: Antibiotic Test ANVISA Registration Number: 10158120623 Class of Risk: II - Medium Risk Model affected: Family - E-test

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMERIEUX BRASIL INDUSTRIA E COMERCIO LTDA; BIOMERIEUX S.A..

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
    2056
  • Date
    2016-12-21
  • 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
    We recommend to users the following actions: 1). Paralyze the use of units that may still be in your inventory. 2). Return the form in Annex I of the Letter to Customers, where you must provide us with the following data: number of units used, number of units still stocked at the institution, for each lot listed in the annex. 3) Block and segregate all Etest units, attached to the references and lots listed in Annex I, which may have in their inventory. BioMérieux will collect them as soon as it receives the return of the form Annex II of the Charter to the clients. 4) We request that you review with your technical team the need or not, to repeat the tests performed with these lots in the future. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    An overall assessment was initiated for all etest molecules for clinical use. this work included reviewing the current stability support data. this includes the data from the previous manufacturer, the stability data generated by the routine stability program and the data generated through the change controls performed on some molecules. there are 3 different presentations, depending on the molecule: foam (foam cartridge): 30 or 100 strips; blister (30 or 100 strips) and single pack (30 individual strips). we emphasize that a capa (corrective and preventive action) was opened at the product manufacturer site to investigate and determine the root cause of this problem and that further stability studies are underway / have been completed to redefine the shelf life of the attached related references . in due time, they must return to the market with revised expiration dates. patient outcomes may also be elevated, presenting false-resistant or false-sensitive results.
  • Action
    Field Action Code FSCA 3193 launched under the responsibility of the company BIOMERIEUX BRASIL INDUSTRIA E COMERCIO LTDA. Company will collect for further destruction of the product.

Device

Etest Ciprofloxacin, Etest Ciprofloxacin, Etest Vancomycin, Etest Vanipycin, Etest Benzyl Penicil...

Manufacturer

BIOMERIEUX BRASIL INDUSTRIA E COMERCIO LTDA; BIOMERIEUX S.A.