China NMPA Product Recall - Human chorionic gonadotropin test strip

Beijing Youshengran Biotechnology Co., Ltd. initiated a voluntary Level III recall of its Human Chorionic Gonadotropin (HCG) Test Strips, as announced by the National Medical Products Administration (NMPA) on November 22, 2018. This action addresses critical labeling and packaging deficiencies identified during the company's self-inspection. The primary issues involved inconsistencies between certain product labels and their official registration information, alongside the presence of non-standard text on packaging boxes. These violations fall under the regulatory purview of the NMPA, which oversees medical device compliance in China. Affected products include HCG Test Strips sold under the trademarks "Yijianling" (card type), "Zhixin" (pen type), and "Ruyi" (pen type), encompassing specific batches such as 180806, 180418, 180604, 180903, 180404, 180801, and 181008. A total of 122,432 units were distributed within China. To rectify these issues, the company committed to destroying all existing non-compliant packaging materials from its inventory. For products already sold, Beijing Youshengran Biotechnology Co., Ltd. is undertaking to replace them with newly packaged items and return them to operating units promptly, aiming to mitigate any operational losses. This proactive measure ensures regulatory alignment and product integrity for devices used in early pregnancy detection.