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 test kits have out-of-range-low (oorl) flucytosine qc results for candida krusei atcc 6258.
조치
The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
제품 설명
Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.