Trade name: Etest family. Technical Name: Microorganism Identification / Antibiogram Device. ANVISA registration number: 10158120623. Class of risk: II. Affected model: Etest Polymyxin B. Serial number affected: 1002446640; 1002559300; 1002639240; 1002735070; 1002797130; 1003187220; 1003230410; 1003288010; 1003538020; 1003655420; 1003957060; 1004164300; 1004193060; 1004296350; 1004348480; 10044414690; 1004773920; 1004951670; 1005020680; 1005161530; 1005325780; 1005329410; 1005497750; 1005558710; 1005753830; 1005945380; 1002280140; 1002431510; 1002605340; 1002762220; 1002797270; 1003006080; 1003230380; 1003322180; 1003553910; 1003655460; 1003719640; 1004164310; 1004347610; 1004370570; 1004530070; 1004767110; 1004838770; 1004955950; 1005020690; 1005329420; 1005536040; 1005659460; 1005716410; 1005851010 의 안전성 경고

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.

Customers should be advised of nonconformity along with instructions to continue use of the impacted product with the limitation of not testing Pseudomonas and Acinetobacter strains with the Etest Polymyxin B product. Use is only recommended for Enterobacteriaceae. For tests released prior to this communication, we recommend that you identify any possible false-sensitive results that may have occurred for Pseudomonas aeruginosa and Acinetobacter in order to analyze the related risks and determine appropriate actions, if relevant. 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 option; Entity, 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