China NMPA Product Recall - Disposable capillary blood collection container

On May 16, 2019, BD Medical Devices (Shanghai) Co., Ltd. announced a voluntary Class II recall concerning specific batches of its disposable capillary blood sampling containers. The company initiated this action after identifying a potential manufacturing issue where certain containers may be damaged. This defect can lead to a reduced fill volume, consequently resulting in an insufficient blood sample for analysis. Such an outcome carries the significant risk of producing erroneous diagnostic results, which could potentially impact patient care and treatment decisions. The affected products are identified by Registration Certificate Nos. 20152412372 and 20152413295. This recall was reported to the Shanghai Food and Drug Administration Medical Device Registration Center, operating under the broader regulatory framework of the National Medical Products Administration (NMPA). As a required action, BD Medical Devices (Shanghai) Co., Ltd. is responsible for effectively implementing this recall to address the discovered quality concern and mitigate any risks to patient safety. The detailed scope, including specific models, specifications, and batch numbers involved in this recall, is comprehensively outlined in the accompanying "Medical Device Recall Event Report Form" provided by the company.