cobas b 221 instruments with AutoQC module 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.

The cobas b 221 instruments are point of care systems used for the determination of multiple blood gas and metabolic parameters, as well as electrolytes. Automated QC measurements may be used to ensure system validity. The reported software limitation issue affecting automatic QC measurements does not directly impact patient results. However, the absence of quality control results may lead to erroneous patient results caused by an unrelated system issue to remain undetected. Erroneous patient results (high, normal, or low) may lead to wrong or delayed diagnosis and/or treatment.