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
Nucleic Acid Amplification Assay System, (Group b streptococcus, direct specimen test) - Product Code NJR
원인
Labeling error: some cartridges may be mislabeled as "xpert ev" instead of "xpert gbs". (the information embedded in the barcode label on the cartridge is correct for xpert gbs and brings up the gbs assay definition file).
조치
Consignees were sent a Correction and Removal letter on 09/04/2007, notifying them that there was a labeling error with some of the cartridges labels indicating Xpert EV instead of Xpert GBS on the cartridge label. They are asked to discontinue using it immediately and return to Cepheid.