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
Antigens, all groups, streptococcus spp. - Product Code GTY
원인
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
조치
On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.
Nationwide Distribution, including Puerto Rico and the country of Canada.
제품 설명
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. || Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.