China NMPA Product Recall - dyeing machine

Sakura Seiki Co., Ltd., in collaboration with its agent Sakura Medical Technology (Taizhou) Co., Ltd., issued a voluntary Class II recall for 65 staining machines (DRS-Prisma-P-JCS model) in China. This action was reported to the National Medical Products Administration (NMPA) on January 8, 2020, and publicly announced on January 14, 2020, to address a manufacturing defect. The core issue involves a faulty CPU board on the operating panel, causing the devices to unexpectedly stop during operation. This malfunction can lead to interrupted staining and potential over-staining of specimens. However, the company asserts that even over-stained specimens remain diagnosable after appropriate treatment, and no health-related incidents have been reported. Under the NMPA's regulatory guidance, Sakura Medical Technology (Taizhou) Co., Ltd. is implementing immediate corrective measures. These include dispatching customer letters to notify all affected parties and sending engineers to replace the defective CPU boards on the 62 units already sold, free of charge. The remaining three units in inventory will undergo CPU board replacement before they are made available for sale, ensuring full remediation of the product line.