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
Calculator/data processing module, for clinical use - Product Code JQP
원인
If result codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the view assay button in the
specimen history screen to open another assay, and then returns back to the original assay.
조치
Perkin Elmer began notifying US customers January 15, 2009. Notification included instructions for how to avoid the situation and instructions for how to obtain a correction. The firm requested consignees to send in a Response Form by fax (358-2-2678-357) or by email (TurkuQMresponse@perkinelmer.com).
For further information, please contact your closest Specimen Gate support center at specimen.gate.support@perkinelmer.com for North America and specimengatesupportfi@perkinelmer.com for outside of North America.
Worldwide Distribution -- United States (AL, AZ, CA, CO, CT, FL, GA, IN, KS, KY, MI, MO, OH, OK, OR, TN and TX) and Canada.
제품 설명
Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. || The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.