China NMPA Product Recall - Mycobacterium tuberculosis specific cellular immunoreaction detection kit (immunospot assay) T-SPOT.TB

Oxford Immunotec Ltd., a medical device manufacturer, is voluntarily recalling a specific model and batch of its Mycobacterium Tuberculosis Specific Cellular Immunoassay Kit (Immunodosed Method) T-SPOT.TB. The recall, categorized as Class III, was initiated due to an identified error in the product expiration date printed on the labels of the affected kits. This issue was reported by Oufide (Shanghai) Medical Device Co., Ltd. The National Medical Products Administration (NMPA) published this recall information on December 16, 2022, under index number JGXX-2022-10295. While the document does not specify inspection dates, it clearly outlines a manufacturer-initiated corrective action in response to a labeling inaccuracy. The regulatory framework for this action falls under the purview of the NMPA, which oversees medical device safety and quality in China. The primary required action by the company is the execution of this voluntary recall to address and rectify the labeling discrepancy, ensuring product integrity and compliance. Further detailed information regarding the affected models, specifications, and batch numbers is provided in the "Medical Device Recall Event Report Form" attachment.