China NMPA Product Recall - Insulin pump (Model: ACCU-CHEK Spirit Combo), Insulin pump (Model: ACCU-CHEK Spirit)

Roche Diagnostics Products (Shanghai) Co., Ltd., in collaboration with its manufacturer Roche Diagnostics GmbH, initiated a voluntary Class II recall for its ACCU-CHEK Spirit Combo and ACCU-CHEK Spirit Insulin Pumps. This recall, reported to the National Medical Products Administration (NMPA) on April 20, 2015, addressed a critical operational issue. The core problem, identified through customer complaint analysis, involved insulin dripping into the reservoir chamber due to improper handling during reservoir replacement. This leakage damaged the internal screw or piston rod, leading to device malfunction, often indicated by E6 and E10 error messages, which could limit or disable the pump's function. Although the potential for serious health harm was assessed as extremely low, the functional impairment was significant. Operating under the NMPA's regulatory framework for medical devices, Roche outlined several required corrective actions. While sales of these specific models had ceased in September 2013, ongoing service commitments necessitated intervention. Roche committed to distributing notification letters and comprehensive operational training materials to all affected distributors, hospitals, and individual users. These materials were also integrated into after-sales service product inventories. Additionally, the company pledged to offer direct support through a customer care hotline for inquiries and guidance, and to conduct training for distributors and relevant medical personnel to ensure correct device handling and prevent future occurrences.