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
Dna-reagents, neisseria - Product Code LSL
원인
Cepheid has received reports that some of our customers have experienced a higher number of
temperature drift errors than would typically be expected when using this test and its intended use
specimen types. investigation of the issue also revealed an occasional probability of false
negative results which remains consistent with package insert claims.
조치
An Urgent Medical Device Recall letter (response form included), dated October 9, 2017, was sent to affected consignees. The letter identified the affected product, the issue involved, impact, and actions to be taken. Cepheid will provide replacement product for Xpert CT/NG assay product identified in this recall. Customers are to complete and the return the Response Form provided in order to receive replacement product. Additionally, the letter instructs users to review their laboratory statistics to see if their positivity rates are trending low during use of the affected lots. If so, they are to review the negative patient results according to their laboratory's Quality Management System. Customers are to refer to the applicable contact information provided if there are any questions.