China NMPA Product Recall - Sample processing system cobas p 501/701

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its Sample Processing System cobas p 501/701, as reported by the National Medical Products Administration (NMPA) on May 27, 2019. The recall stems from an investigation into customer complaints, which revealed a manufacturing issue where screws on the tray holder input area flap of the system could loosen. This defect potentially causes the flap to detach from the instrument, posing a risk of temporary ankle or foot injury if it falls onto a user. The affected product, registered under Shanghai Food and Drug Administration Medical Device Registration Certificate 2019-119, is being recalled to address this safety concern. Roche Diagnostics' proactive measure underscores its commitment to product safety and compliance with regulatory standards, ensuring all affected devices are managed according to the detailed information provided in the "Medical Device Recall Event Report Form."