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
in vitro diagnostic analyzer software - Product Code CHL
원인
The abl8o flex software version 1.10 contains errors in the derived parameter calculation for cbase(b,ox) and cbase(ecf,ox). these incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. elevated hemoglobin concentrations have the greatest impact on this calculation err.
조치
A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice.
Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.