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.
Contamination from gsp shaker unit results in decreased signal activity of assay measurements for genetic screening for neonatal irt, tsh and irt.
조치
PerkinElmer sent an Urgent: Medical Device Recall letter dated June 27, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement units of the recalled product will be installed as soon as they are available. Customers were instructed to complete and return the response form attached. For further information contact your local PerkinElmer representative or GS. Technical.Support@PerkinElmer.com
Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
제품 설명
Perkin Elmer Genetic Screening Processor (GSP) || Product Code: 2021-0010 || Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.