Events

Safety Alert for E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affected model: n / a Serial numbers affected: - Reference number 537300: 100483220 , 1004437930,1004329220,1004190730,1004171220,1003969990,1003767080,1003725600,1003610660,1003532330,1003514810, 1003409250,1003297790,1002849110,1002816570,1002780680,1002594030,1002517610,1002438560,1002336190,1002154530,1001742150,1001496200,1001417080 1001260560.1001158900, 1000941970,1000893880,1000756330 and 1000714690. - Reference 537308: 10044750,1002523000,1002703940,1002795210,1002889130,1002989530,1003456440,1003456440 1003616140,1003767090,1004177660,1004596710,1004752310 and 1002343060

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux 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
    2007
  • Date
    2016-08-10
  • 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
    According to company information: 1- Share the information with all laboratory staff. 2- Continue the use of the E-test Colistin CO256 for diagnosis of strains of Enterobacteriaceae, only if done in conjunction with Mueller Hinton E of bioMérieux. 3- If the client does not use Mueller Hinton E from bioMérieux, or if other strains other than Enterobacteriaceae are tested, we recommend the restricted use of the E Colistin CO256 E-test for epidemiological surveys. As this is a test only for use by healthcare professionals, it does not fit recommendations to patients. ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Reason
    Based on scientific publications (including eucat) on gradient tests and colistin diffusion discs, including e-test (ref .: 537300 and 37308), biomérieux was alerted to a potential underestimation of mic values ​​for enterobacteriaceae and acinetobacter microorganisms . biomérieux began an investigation to confirm the performance of the product and determine the root cause of the problem.
  • Action
    Field Action No. FSCA 3061, triggered under the responsibility of the company bioMérieux SA Risk classification: II Classification of the field action: Sending of guidance letter to the customers who acquired the lots distributed in Brazil. Sample letter attached to this form.

Device

E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affe...

Manufacturer

bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A.