China NMPA Product Recall - Fully automated biochemical analyzer

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. initiated a voluntary Level III recall for specific models of its fully automated biochemical analyzers, impacting approximately 110 units sold across China. This action, reported to the National Medical Products Administration (NMPA) on July 16, 2019, stemmed from an internal finding during production: the ion selective electrode (ISE) stability test for certain products did not consistently meet established process requirements. The identified issue posed a risk of occasional daily quality control test failures and the triggering of operational alarms, potentially affecting the accuracy and reliability of clinical chemical component analysis in various samples like serum, plasma, and urine.

The affected products include models such as BS-800, BS-820, BS-800M, BS-820M, BS-830, BS-850, BS-2000, and BS-2000M. Mindray reported no associated adverse events as of the recall date. To address the non-conformance, Shenzhen Mindray outlined two primary corrective actions: notifying all customers of affected devices through formal letters and subsequently engaging directly with these customers to implement necessary repair interventions. This proactive recall underlines the company's commitment to product safety and compliance with NMPA medical device regulations.