RAPIDLab 1200 SYSTEMS - Registration No. 10345160455; RAPIDPoint 400 Series - Registration No. 10345160460; RAPIDPoint 500 SYSTEM - Registration No. 10345161877. Serial numbers attached to the alert. 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.

According to the company's statement, mistakes in identifying the sample may lead to the release of incorrect patient results and inappropriate treatment. The clinical results of blood gas analyzers are not interpreted in isolation and inadequate conduct is rare since the physician, through other findings, knows the expected result. Blood gas analyzers are employed in clinical practice and the tests are used to correlate clinical and biochemical findings with optimal treatment and conduct to the patient. Changes in therapy, such as oxygenation rate, would be followed by a repeat test. Patient monitoring would also alert the physician to the potentially discordant outcome, preventing the occurrence of harm.