China NMPA Product Recall - Prealbumin Assay Kit (Immunoturbidimetric Method)

Shanghai Gene Technology Co., Ltd. initiated a voluntary Class III recall of its Prealbumin Assay Kit (Immunoturbidimetric Method) on May 30, 2019, as reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by an labeling error: the production date on the product labels was incorrect, although the expiration date remained accurate. The company confirmed that, at the time of the recall, no customer complaints or adverse events related to this specific labeling discrepancy had been reported. This proactive measure by Shanghai Gene Technology Co., Ltd. demonstrates adherence to regulatory responsibilities under the NMPA framework by addressing product non-conformities to ensure label accuracy and maintain product integrity, despite the low risk associated with the incorrect production date. Affected product details, including models, specifications, and batch numbers, were provided in an attached "Medical Device Recall Event Report Form" for stakeholders.