RAPIDPOINT 500 SYSTEM; Registration 10345161877, Serial Nos: 33897; 34218; 34225; 34227; 34516; 34502; 34515; 34497; 34607; 34608; 34611; 34975; 34990; 34982; 34977; 34974; 34986; 35098; 35097; 35096; 35664; 35671; 35669; 35667; 35672; 35666; 35729; 35680; 35728; 35726; 35724; 35979; 36044; 36601; 36604; 36603; 36693; 36697; 36683; 36639; 36819; 36814; 36813; 36818; 36812; 36811. (Annex 1) 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The record holder informs that duplicate or missing analyte as described above, poses no health risk. The results are readily available in the instrument for consultation and referral to the HIL. The health risk is limited to the extremely unlikely situation in which an analyte when being analyzed is switched between two patients. A transfected result of sodium, potassium, glucose, lactate, carboxyhemoglobin, methaemoglobin, or neonatal bilirubin may lead to a potential health risk when the actual value is critical. In all cases, the probability of occurrence is extremely unlikely due to the low frequency of occurrence of the software problem and correlation with the clinical presentation of the patient, history and laboratory tests.