U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Susceptibility test cards, antimicrobial - Product Code LTW
원인
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
조치
bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. || For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.