China NMPA Product Recall - Identification of Gram-positive bacteria and breakpoint antimicrobial susceptibility testing

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Gram-Positive Bacteria Identification and Breakpoint Susceptibility Testing Plate. This action, reported on April 8, 2019, followed the discovery of insufficient growth in the product's growth wells during quality control experiments utilizing the M. luteus ATCC 49732 strain. This issue potentially compromises the accuracy and reliability of diagnostic tests performed with these plates. The recall was reported to the National Medical Products Administration (NMPA) and falls under the oversight of the Shanghai Food and Drug Administration, as indicated by the product's registration certificate (CFDA (Imported) 2014 No. 2403578). The company's proactive recall aims to mitigate any potential risks to patient care that could arise from inaccurate diagnostic results. Specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This recall underscores the importance of stringent quality control in medical device manufacturing and post-market surveillance to ensure product integrity and patient safety.