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
Reagent, general purpose - Product Code PPM
원인
A drift of the performance with the bk test (bk virus, worst case application) was observed for some silica batches of magnetic silica (magsil). this is the same issue as in recall z-2342-2016.
조치
Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016.
Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
제품 설명
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, || Product Usage: || NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.