China NMPA Product Recall - Blood gas, blood oxygen, electrolyte and metabolite analyzer

On June 19, 2017, Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Blood Gas, Blood Oxygen, Electrolyte, and Metabolite Analyzers (Registration No.: CFDA (Imported) No. 20142403525). This action, indexed by the National Medical Products Administration (NMPA) as JGXX-2017-10481, was prompted by identified operational malfunctions within the device.

The main issues reported include product malfunctions when users manually exit the adjustment mode after replacing a test card. Additionally, the analyzer exhibits malfunctions when specific blood sample types, namely "umbilical artery blood" or "umbilical vein blood," are input into the system. These deficiencies could potentially affect the accuracy and reliability of diagnostic data generated by the device.

Radomet Medical Equipment (Shanghai) Co., Ltd. proactively reported these concerns to the NMPA. The company is undertaking this voluntary recall to address the identified product flaws, uphold product integrity, and ensure the safety and accuracy of clinical results. Detailed information on affected product models and scope is available in the associated Medical Device Recall Event Report Form.