China NMPA Product Recall - ABL800 FLEX series blood gas analyzer

Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall on July 3, 2019, for its ABL800 FLEX series blood gas analyzers. The recall, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses a critical patient safety concern. The primary issue arises when these analyzers are configured for bidirectional data communication with AQURE, Radiance, or HIS/LIS systems, and the "Patient Information Confirmation" feature is actively engaged. Under these specific conditions, there is a potential risk of patient data confusion during information retrieval from the connected systems. While this feature is disabled by default, its activation creates the vulnerability. To mitigate this risk and ensure patient safety, Radomet Medical Equipment (Shanghai) Co., Ltd. voluntarily recalled the affected devices, providing detailed information on specific models and batches in the accompanying "Medical Device Recall Event Report Form." This action underscores the company's commitment to compliance and patient well-being under regulatory guidance.