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

Radomet Medical Equipment (Shanghai) Co., Ltd. has issued an updated Class III voluntary recall for its Blood Gas, Blood Oxygen, Electrolyte and Metabolite Analyzers. Published by the National Medical Products Administration (NMPA) on March 5, 2020, this update amends the previous Shanghai Food and Drug Administration Medical Device Recall No. 2019-286. The initial concern stemmed from a perceived measurement deviation in total bilirubin (tBil) for newborns detected by the analyzers' hemolyzer. However, further investigation revealed that this specific deviation actually meets the product's technical requirements when used for newborns. Consequently, no special actions are now required for instruments utilized in newborn applications, necessitating a revision of the original recall strategy. The regulatory oversight for this action involves both the Shanghai Food and Drug Administration, which initiated the original recall, and the NMPA, responsible for the official announcement. Radomet Medical Equipment is required to update its recall strategy, with comprehensive details on affected product models, specifications, and batches provided in the accompanying Medical Device Recall Event Report Form.