China NMPA Product Recall - Lactic acid detection test strips (reflection spectrophotometry)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Lactic Acid Detection Test Strips (Reflection Spectrophotometry). This action, published by the National Medical Products Administration (NMPA) on January 18, 2019, addresses a significant performance issue identified by Roche Diagnostics headquarters. The core problem centered on the product's performance at higher altitudes. While the test strip's instructions stated applicability for lactate measurement at altitudes not exceeding 3000 meters, internal testing revealed measurement results at 3000 meters deviated beyond acceptable error ranges. Conversely, results at 2000 meters remained within specified limits, indicating a critical discrepancy between stated product capabilities and actual performance under specific environmental conditions. This recall, impacting products registered under certificate number CFDA (Imported) 2013 No. 2403786, was a company-initiated corrective action to address the identified safety and efficacy concerns related to the altitude limitation. Details regarding specific models, specifications, and affected batches were provided in a "Medical Device Recall Event Report Form." The voluntary recall underscores the company's commitment to product safety and compliance with medical device regulations overseen by authorities like the NMPA.