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
When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result.
조치
Clients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the potential hazard, root cause, corrective action, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software.
SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Version 4.0.1.14 Manufactured & Distributed 12/29/2006. || Version 4.0.1.15 Manufactured & Distributed 05/02/2007. || Version 4.0.1.16 Manufactured & Distributed 08/22/2008. || Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.