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
On 10/17/2011 scc soft computer, clearwater, fl initiated a correction on softlab with sa inst versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. a client reported an issue which caused two different sets of results from the sysmex series of hematology instruments to display under the same order on the instrument menu.
조치
SCC Soft Computer's proprietary Task Management System sent a correction communication letter to all consignees with affected software. The letter identified the affected product, problem and corrective actions to be taken. The letter also recommended alternative working solution if the corrective actions cannot be used. Consignees with affected software are scheduling receipt of the software correction. For questions call 727-789-0100.
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. || Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.