China NMPA Product Recall - Activated Partial Thromboplastin Time Assay Kit (Coagulation Method) HemosIL SynthAsil

Instrumentation Laboratory Co., in conjunction with its reporting entity Wofen Medical Devices Trading (Beijing) Co., Ltd., has initiated a voluntary Class II recall for specific batches of its Activated Partial Thromboplastin Time Assay Kit (Clotting Method), known as HemosIL. SynthAsil (National Medical Device Registration Certificate No. 20162404613). This significant regulatory action, publicized by the National Medical Products Administration (NMPA) on April 23, 2023, addresses a critical product performance issue. The primary violation identified is that certain batches of the assay kit failed to meet the specified 24-hour stability requirements outlined on the product label. This deficiency indicates that the kits may not maintain their diagnostic reliability for the entire stated shelf life after initial preparation, potentially affecting the accuracy of patient test results. The NMPA oversees this recall, underscoring the stringent regulatory environment for medical devices in China. The required actions involve an immediate and active recall of all impacted product models, specifications, and batch numbers, as detailed within the provided 'Medical Device Recall Event Report Form.' Healthcare providers and distributors are instructed to discontinue use of the affected kits and adhere to the manufacturer's established recall procedures to remove these non-compliant products from circulation, thereby safeguarding diagnostic integrity and patient safety.