China NMPA Product Recall - Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) Nucleic Acid Detection Kit (Multiplex Real-Time Fluorescent PCR) Xpert CT/NG Assay

Cepheid AB, a manufacturer of medical diagnostic products, through its distributor Cepheid (Shanghai) Trading Co., Ltd., has initiated a voluntary Class III recall for specific batches of its Nucleic Acid Detection Kit for Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) (Multiplex Real-Time Fluorescent PCR), also known as Xpert CT/NG Assay. This action was reported to the National Medical Products Administration (NMPA) of China on June 14, 2023. The primary reason for the recall is the discovery that certain pipette components included in the kits were found to have an expiration date preceding the overall kit's expiration date. This discrepancy could potentially affect the accuracy and reliability of the diagnostic test results if used with expired pipettes. As part of the established regulatory framework governed by the NMPA, the company proactively reported this issue, leading to the voluntary recall. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information concerning the affected product models, specifications, and batch numbers is available in an attached "Medical Device Recall Report Form." This recall ensures compliance with medical device regulations and maintains product integrity for patient safety.