China NMPA Product Recall - Brain natriuretic peptide precursor assay kit (electrochemiluminescence assay)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Brain Natriuretic Peptide Pre-Assay Kit (Electrochemiluminescence Imaging) on April 24, 2020. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), stemmed from a customer complaint regarding inconsistent production dates. The primary issue involved a discrepancy where the production date displayed on the Chinese label of batch number 41300501 did not match the date on the English label. An internal investigation conducted by Roche Diagnostics confirmed this inconsistency was a result of human error during the labeling process, affecting only some of the Chinese labels for the specified batch. In response to this labeling inaccuracy, the company proceeded with a voluntary recall to address the non-conforming product. Further details regarding the specific models, specifications, and affected batch numbers are available in the "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to product integrity and compliance with regulatory standards.