Beckman Coulter, Inc. Recall

On July 2020, Beckman Coulter, Inc. (the manufacturer) voluntarily recalled the LDH (product name) due to the content differences in its English and Chinese IFU. The English IFU describes the stability of bottle opening for 21 days; however, the Chinese IFU describes the stability of bottle opening for 30 days. This is a Class III recall, for which is less likely to cause harm but still requiring a recall. Since China NMPA enhances the post-market surveillance, China Med Device can lead manufacturers in compliance with China regulations.

Link: http://www.nmpa.gov.cn/WS04/CL2135/378855.html