L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는
France
에서 BECTON DICKINSON BIOSCIENCES 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
데이터 추가 비고
조치
The batches 9342298 (per 01.07.01) and 9327298 (per 01.10.01) of the reagent denominated BD BACTEC SIRE reference 442102, of the company BECTON DICKINSON BIOSCIENCES are withdrawn from the market following a mislabeling. A new test is recommended for samples that have been found either resistant to streptomycin and isoniazid, or sensitive to streptomycin and isoniazid.