China NMPA Product Recall - Nucleic Acid Extraction Reagent BD MAX™ ExK™ TNA-3

Becton, Dickinson and Company initiated a voluntary Class III recall of its Nucleic Acid Extraction Reagent BD MAX

ExK

TNA-3 (Registration Certificate No.: 20170403). The National Medical Products Administration (NMPA) publicly reported this action on March 18, 2022. The recall was prompted by an issue where specific models and batches of the reagent may have been exposed to temperatures exceeding the product's established stability claims. This potential temperature excursion could impact the reagent's efficacy and reliability. The recall was reported by Becton, Dickinson Medical Devices (Shanghai) Co., Ltd., on behalf of the manufacturer. This action falls under the NMPA's regulatory framework for medical device safety in China. As a Class III recall, the situation indicates a low probability of causing adverse health consequences. The required action involves the removal of affected products from the market, with detailed information on specific models, specifications, and batch numbers provided in a "Medical Device Recall Event Report Form" to ensure efficient resolution and maintain product quality standards.