China NMPA Product Recall - Motor neuron survival gene 1 (SMN1) exon deletion detection kit (quantitative PCR method)

On August 4, 2020, Shanghai Wuseshi Medical Technology Co., Ltd. initiated a voluntary Class III recall of its Motor Neuron Survival Gene 1 (SMN1) Exon Deletion Detection Kit (Quantitative Real-Time PCR Method). This action, overseen by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration, was prompted by an inconsistency in product information. The company identified that the product instructions specified two storage conditions and expiration dates, while the accompanying product label only indicated one. Additionally, the instructions directed users to "See label" for storage conditions, creating a potential for customer confusion due to this discrepancy. Importantly, Shanghai Wuseshi Medical Technology Co., Ltd. confirmed that this labeling issue did not affect the performance, intended use, or test results of the medical device. As a corrective measure, the company is recalling all unused batches of the affected kits to replace the product labels, ensuring clarity and consistency for consumers. This voluntary recall demonstrates the company's commitment to accurate product information, even for issues not impacting product efficacy or safety.