China NMPA Product Recall - ABL90 FLEX Analyzer for blood gas, blood oxygen, electrolytes and metabolites

Radiometer Medical ApS, through its subsidiary Radiometer Medical Devices (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its ABL90 FLEX Analyzers. This action, published on April 17, 2024, under National Medical Products Administration (NMPA) Index No. JGXX-2024-10061, addresses issues with blood gas, blood oxygen, electrolyte, and metabolite analyzers. The core problem identified is the installation of unreleased software on these devices, prompting the manufacturer to take corrective measures.

While specific inspection dates are not detailed in the document, the recall notice highlights a proactive response from the company to a significant software discrepancy. The NMPA serves as the primary regulatory body overseeing this recall in China, ensuring compliance with medical device standards. A Class III recall typically indicates that the use of or exposure to the affected product is unlikely to cause severe adverse health consequences.

The required action involves the recall of all impacted units. Further detailed information regarding the affected product models, specifications, and batch numbers is available in the