China NMPA Product Recall - CLINITEK Novus Automated Urine Chemistry Analyzer

The National Medical Products Administration (NMPA) has publicized a Class II voluntary recall by Siemens Healthcare Diagnostics Inc., concerning its CLINITEK Novus Automated Urine Chemistry Analyzer. Announced on November 21, 2025, this recall addresses a critical software anomaly in analyzer software version 1.4.1. The core issue involves the potential for the CLINITEK Novus system to produce inaccurate quality control results. Specifically, when the analyzer is used with third-party quality control products—those not manufactured by Siemens Healthcare—it may erroneously report either false quality control failures or false passes. This malfunction presents a significant risk to the accuracy and reliability of diagnostic testing, potentially leading to misinterpretations of patient data and subsequent inappropriate clinical interventions. Siemens Healthcare Diagnostics Inc. initiated this voluntary recall to proactively mitigate these diagnostic risks. The NMPA's classification of this as a Class II recall signifies that the use of or exposure to the affected product could cause temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Facilities utilizing the CLINITEK Novus system are required to consult the attached "Medical Device Recall Event Report Form" for comprehensive details on specific affected product models, specifications, and batch numbers. This ensures all necessary steps can be taken to resolve the identified software deficiency and uphold the integrity of urine chemistry analyses.