China NMPA Product Recall - BD Phoenix™ AST Indicator Solution, a streptococcal antimicrobial susceptibility indicator.

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its BD Phoenix™ AST Indicator Solution (Streptococcal Antimicrobial Susceptibility Indicator), as announced on January 31, 2019. This action updated an earlier warning issued on December 26, 2018, escalating it to a full product recall. The regulatory oversight for this action falls under the National Medical Products Administration (NMPA) and is referenced in the Shanghai Food and Drug Administration (SFDA) Notice No. 2018-314 (Update 1).

The core issue prompting the recall is that certain batches of the indicator solution caused test plates to prematurely terminate within 45 minutes after being loaded into testing instruments. This malfunction could lead to incomplete or unreliable antimicrobial susceptibility test results, potentially impacting clinical decisions. Customers utilizing affected product batches may receive specific notifications from their instruments regarding these interruptions. The recall applies to products registered under Certificate Nos. 20150096 and 20142405397. Comprehensive details, including specific models, specifications, and batch numbers subject to the recall, are provided in the "Medical Device Recall Event Report Form," requiring immediate attention from users.