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
General Purpose, microbiology, diagnostic Medical Device - Product Code LIB
원인
The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. this could lead to a "false" negative growth result.
조치
The firm sent a recall notification letter to all of their consignees on 2/10/2014.