China NMPA Product Recall - Albumin calibrator

The National Medical Products Administration (NMPA) released information on January 19, 2012, concerning a global product recall initiated by Ortho Clinical Diagnostics, Inc. for specific generations (GENS 06, 07, 08, and 09) of its Albumin Calibrators. This recall was reported to the NMPA on January 10, 2012, by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the responsible unit in China. The core issue prompting the recall is that results obtained using these calibrators "may be biased," indicating potential deviations in diagnostic accuracy. However, the manufacturer noted that previously reported results are considered acceptable if quality control measures were within specified limits. While the recall is global, Ortho Clinical Diagnostics confirmed that the affected products were not present in the Chinese market within their expiration dates. Consequently, no direct corrective actions, such as product retrieval, were applicable in China. The NMPA's regulatory response instructed provincial, autonomous region, and municipal food and drug administrations to strengthen their supervision and management of similar products to maintain product safety and compliance.