China NMPA Product Recall - Luteinizing hormone (LH) test strip (colloidal gold immunochromatography)

Nantong Yishi Biotechnology Co., Ltd. initiated a Class III voluntary recall of its Luteinizing Hormone Test Strips (Colloidal Gold Immunochromatography) on March 14, 2019. This action followed a medical device sampling inspection conducted by the Liaocheng City Food and Drug Administration in Shandong Province, which identified that a specific product batch, 1804170201, failed to comply with established technical requirements. The primary issue was the product's inability to meet technical requirements 2.2 and 2.4 of its official product filing, indicating a deviation from approved quality standards for the in vitro diagnostic device. The recall affects 200,200 doses of the diagnostic product, which is used for the qualitative detection of luteinizing hormone in human urine. Under the regulatory framework of the National Medical Products Administration (NMPA) of China, Nantong Yishi Biotechnology Co., Ltd. is required to manage this recall across China. The company must document all details of the affected products and implement appropriate corrective actions and handling methods to address the identified non-compliance and ensure future adherence to quality standards.