China NMPA Product Recall - Direct bilirubin assay kit (endpoint diazo method)

On May 8, 2019, Fujifilm (China) Investment Co., Ltd. announced a voluntary Class III recall for specific batches of its Direct Bilirubin Assay Kit (Diazo Method). The recall was prompted by the discovery of a printing error on the Chinese instructions for use, where an incorrect expiration date was listed. This discrepancy in critical product information necessitated immediate action to prevent any potential misinterpretation by users. The issue was formally reported to regulatory bodies, identified under the National Medical Products Administration (NMPA) Index No. JGXX-2019-10303 and the Shanghai Food and Drug Administration Recall No. 2019-110. A Class III recall signifies that while a product defect exists, it is unlikely to cause serious adverse health consequences. As part of its required actions, Fujifilm (China) Investment Co., Ltd. initiated the retrieval of the affected kits from the market. The company also made available a "Medical Device Recall Event Report Form" containing comprehensive details on the involved product models, specifications, and batch numbers. This transparent and voluntary recall by Fujifilm underscores its commitment to product quality, patient safety, and adherence to established regulatory guidelines concerning medical device instructions and labeling.