China NMPA Product Recall - Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method)

Jiangsu ShuoShi Biotechnology Co., Ltd. has initiated a voluntary Level III recall for its Novel Coronavirus 2019-nCoV Nucleic Acid Detection Kit (Fluorescent PCR Method). This measure was reported to the relevant Provincial Drug Administration, operating under the National Medical Products Administration (NMPA) regulatory framework in China. The primary reason for the recall was the detection of abnormal temperatures during the transportation of the kits. Although the company's internal research and verification concluded that product quality was not adversely affected by these temperature excursions, a proactive decision was made to recall the product due to the identification of potential risks. The recall specifically targets various batch numbers of the 50 tests/box kit, which are used for the in vitro qualitative detection of the novel coronavirus in clinical samples like nasopharyngeal swabs and sputum. As part of the required corrective actions, Jiangsu ShuoShi Biotechnology Co., Ltd. is notifying all affected customers to return their inventory of the implicated batches. Upon receipt, the company will undertake the destruction of all returned products to ensure no potentially compromised items remain in circulation, upholding product safety and integrity.