China NMPA Product Recall - Cardiac Troponin I Detection Kit (Colloidal Gold Immunochromatography)

Sinopharm Biopharmaceutical Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall for its Cardiac Troponin I Detection Kit (Colloidal Gold Immunochromatography). This decision followed a 2019 national supervision and spot check, which revealed a significant issue: the product's membrane strip width failed to meet the specified technical requirement of not being less than 4.5mm. Zhong Sheng Bei Kong Biotechnology Co., Ltd. is listed as the manufacturer and agent for the recalled device. The affected kit, registered under No.: 京械注准20162400525 with Batch Number 190831, is designed for in vitro qualitative detection of serum cTnL concentration to aid in assessing myocardial damage. Out of 98 units produced, 10 had been sold in China. Corrective actions, reported on July 22, 2019, include suspending sales of the non-conforming batch, issuing recall notices to all purchasers to halt use and sales, actively recalling the products, and ultimately destroying all retrieved units. This action underscores the NMPA's diligent oversight in ensuring medical device quality and patient safety.