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
Functionality issue: for clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. this could cause incorrect results to be populated to a patient record.
조치
Clients were notified via the proprietary communication software on 06/01/2010. The communication discussed the risk-to-health notification task, 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.
Worldwide Distribution -- US, including states of CT, FL, IL, KY, GA, LA, IN, MS, NJ, NY, PA, OH, and TN and country of Canada.
제품 설명
SA BASE with SoftLab Version 3.1.4.x. || Manufactured 03/2003. || SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. || Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.